Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer; Meridian Interbody System; Meridian Anterior Plate System; Reef L Interbody System; Reef TO/TA System; Regatta Lateral System; Regatta Lateral Plate System; Shoreline ACS Interbody System; Shoreline Threaded TruProfile Plate; Shoreline RT Interbody System; Vu Mesh; WaveForm A Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TA Interbody System; WaveForm TO Interbody Sy

Admiral ACP System

The Admiral ACP System is intended for anterior cervical fixation (C2-T1) for the following indications: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudarthrosis, and failed previous fusion.

Explorer TO System

When used as an intervertebral body fusion device, the system is intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). These patients should have had six months of non-operative treatment. The device is intended to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion and supplemental fixation.

Laminoplasty System

The SeaSpine Laminoplasty System is intended for use in the lower cervical and upper thoracic spine (C3 to T3) for laminoplasty procedures. The SeaSpine Laminoplasty System is used to hold the allograft material in place in order to prevent the allograft material from expulsion, or impinging the spinal cord.

Manta Ray TDF Spacer

The Manta Ray TDF Spacer is an interbody fusion device intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C3-T1) for multiple contiguous levels. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment.

The Manta Ray TDF Spacer is intended for use with autograft bone and/or allogenic bone graft composed of cancellous, cortical, and/or corticocancellous bone and supplemental fixation.

Meridian Interbody System

Interbody Device (IBD) Implants (i.e., interbody implants used alone):

The Meridian System with NanoMetalene surface technology Interbody, when used with or without a Spin Plate, is indicated for use as an adjunct to fusion in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). Patients should be skeletally mature and have had at least six (6) months of non-operative treatment. The interbody is intended to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. The Meridian Interbody is intended for use with supplemental fixation.

No-profile Interbody Implants with Screws:

The Meridian System 2-Hole and 3-Hole No-profile Interbody, when used with Screws and with or without a No-profile Locking Cover, is a standalone interbody implant indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device. The interbody is intended to be used with autogenous bone graft and/or allogeneic bone graft composed cancellous, cortical, and/or corticocancellous bone or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. The Meridian System 2-Hole and 3-Hole No-profile Interbody must be used with the maximum number of screws allowed. Hyperlordotic sizes (greater than 20°) are intended for use with supplemental fixation.

The Meridian System 4-Hole No-profile Interbody, when used with Screws and with or without a No-profile Locking Cover, is a standalone interbody implant indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device. The interbody is intended to be used with autogenous bone graft and/or allogeneic bone graft composed corticocancellous bone. The Meridian System 4-Hole Noprofile Interbody may be used as a standalone device only when at least two Screws are inserted with one inferior and one superior screw trajectory. If the surgeon chooses to use the 4-Hole No-profile Interbody with fewer than two Screws inserted with one inferior and one superior screw trajectory, then additional supplemental fixation system must be used. Hyperlordotic sizes (greater than 20°) are intended for use with supplemental fixation.

No-profile Interbody Implants with Inline Fixation Anchors:

The Meridian System No-profile Interbody, when used with Inline Fixation Anchors and a No-profile Locking Cover, is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device. The interbody is intended to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. The Meridian No-profile Interbody with Inline Fixation Anchors is intended for use with supplemental fixation.

TruProfile Interbody Implants:

The Meridian System TruProfile Interbody assembled with the Anterior Plate, when used with Screws, an Anterior Plate Locking Cover, and with or without a Spin Plate, is a standalone interbody implant indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device. The interbody is intended to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. Hyperlordotic sizes (greater than 20°) are intended for use with supplemental fixation.

Meridian Anterior Plate System

The Meridian Anterior Plate System is indicated as additional support during fusion via an anterior or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (T1-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, kyphosis, lordosis, spinal stenosis, or a failed previous spine surgery.

Reef L Interbody System

Interbody Device (IBD) Implants (i.e., interbody implants used alone):

The Reef L Interbody System with NanoMetalene surface technology is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD, defined as back pain of discogenic origin, with degeneration of the disc confirmed by history and radiographic studies). It is intended for use at either one level or two contiguous levels in the lumbar spine, from L1 to S1, for the treatment of DDD with up to Grade 1 spondylolisthesis at the involved level(s). Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device. The interbody is intended to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion.

The Reef L Interbody System is intended for use as an adjunct to fusion in the thoracolumbar spine from T1 to T12 and at the thoracolumbar junction (T12-L1) for the treatment of symptomatic disc degeneration (DDD) or degenerative spondylolisthesis at one or two contiguous levels, including thoracic disc herniation (with myelopathy and/or radiculopathy with or without axial pain). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Reef L Interbody System can also be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity.

The Reef L Interbody System is intended for use with supplemental fixation. Hyperlordotic sizes (greater than 20°) must be used with legally marketed anterior supplemental fixation.

TruProfile Interbody Implants (i.e., interbody implants used with TruProfile Plates):

The Reef L Interbody System assembled with the TruProfile Lateral Plate, when used with Screws, is a standalone interbody implant indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L1 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device. The interbody is intended to be used with autogenous bone graft, allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. The Reef L Interbody System assembled with the TruProfile Lateral Plate, when used with Screws, can also be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity.

The Reef L Interbody System assembled with the 1-Hole TruProfile Lateral Plate, when used with a single Screw, is intended for use with additional legally marketed anterior or posterior supplemental fixation.

Reef TO/TA System

When used as an intervertebral body fusion device, the Reef TO/TA System with NanoMetalene™ surface technology is intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous nonfusion spinal surgery at the involved spinal level(s). These patients should have had six months of non-operative treatment. The device is intended to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion and supplemental fixation.

Regatta Lateral System

Interbody Device (IBD) Implants (i.e., interbody implants used alone):

The Regatta Lateral System with NanoMetalene™ surface technology is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD, defined as back pain of discogenic origin, with degeneration of the disc confirmed by history and radiographic studies). It is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of DDD with up to Grade 1 spondylolisthesis at the involved level(s). The interior of the interbody spacer component may be packed with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device.

The Regatta Lateral System is intended for use with supplemental fixation.

TruProfile Interbody Implants:

The Regatta Lateral System assembled with the TruProfile Lateral Plate, when used with Screws, is a standalone interbody implant indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The interior of the spacer component may be packed with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device.

The Regatta Lateral System assembled with the 1-hole TruProfile Lateral Plate, when used with Screws, is intended for use with supplemental fixation.

Regatta Lateral Plate System

The SeaSpine Regatta Lateral Plate System is indicated as additional support during fusion via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (T1-L5) spine instability or via a lateral or anterolateral surgical approach below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, kyphosis, lordosis, spinal stenosis, or a failed previous spine surgery.

Shoreline ACS Interbody System

The Shoreline ACS Interbody System with NanoMetalene™ surface technology are interbody fusion devices intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) for multiple contiguous levels. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. These devices are to be filled with autograft bone and/or allogenic bone graft composed of cancellous, cortical, and/or corticocancellous bone or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion.

When used as a standalone system, the Shoreline ACS Interbody System, which includes the TruProfile plates and No-profile spacer, is intended to be used as an adjunct to spinal fusion procedures at multiple contiguous levels of the cervical spine (C2-T1) and must be used with bone screw fixation and locking covers. The Shoreline ACS interbody spacers with ≥ 20° lordosis are intended to be used with supplemental fixation.

When the Shoreline ACS Interbody (excluding the Noprofile spacer) is used with supplemental fixation, such as anterior cervical plates, the Shoreline ACS Interbody System is intended to be used as an adjunct to spinal fusion procedures at multiple contiguous levels of the cervical spine (C2-T1).

Shoreline Threaded TruProfile Plate

The Shoreline Threaded TruProfile Plate is intended for anterior cervical fixation (C2–T1) for the following indications:

• Degenerative Disc Disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies),

• Spondylolisthesis,

• Trauma (i.e., fracture or dislocation),

• Spinal Stenosis,

• Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),

• Tumor,

• Pseudarthrosis,

• Failed previous fusion.

Shoreline RT Interbody System

The Shoreline RT Interbody System with NanoMetalene™ surface technology are interbody fusion devices intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) for multiple contiguous levels. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. These devices are to be filled with autograft bone and/or allogenic bone graft composed of cancellous, cortical, and/or corticocancellous bone or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion.

When used as a standalone system, the Shoreline RT Interbody System, which includes the TruProfile plates, is intended to be used as an adjunct to spinal fusion procedures at multiple contiguous levels of the cervical spine (C2-T1) and must be used with bone screw fixation and locking covers. The Shoreline RT interbody spacers with ≥ 20° lordosis are intended to be used with supplemental fixation.

When the Shoreline RT Interbody System is used with supplemental fixation, such as anterior cervical plates, the Shoreline RT Interbody System is intended to be used as an adjunct to spinal fusion procedures at multiple contiguous levels of the cervical spine (C2-T1).

Vu•Mesh

The Vu•Mesh is indicated for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or otherwise unstable vertebral body due to tumor or trauma (i.e. fracture).

The Vu•Mesh system is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. Bone graft material is recommended for packing into the interior opening of the device prior to implantation. The Vu•Mesh system is intended for use with supplemental internal spinal fixation systems.

WaveForm A Interbody System

Interbody Device (IBD) Implants (i.e., interbody implants used alone):

The WaveForm A System Interbody, when used with or without a Spin Plate, is indicated for use as an adjunct to fusion in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). Patients should be skeletally mature and have had at least six (6) months of non-operative treatment. The interbody is intended to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. The WaveForm A System Interbody is intended for use with supplemental fixation.

No-profile Interbody Implants with Screws:

The WaveForm A System 2-Hole and 3-Hole No-profile Interbody, when used with Screws and with or without a No-profile Locking Cover, is a standalone interbody implant indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device. The interbody is intended to be used with autogenous bone graft and/or allogeneic bone graft composed cancellous, cortical, and/or corticocancellous bone or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. The WaveForm A System 2-Hole and 3-Hole No-profile Interbody must be used with the maximum number of screws allowed. Hyperlordotic sizes (greater than 20°) are intended for use with supplemental fixation.

The WaveForm A System 4-Hole No-profile Interbody, when used with Screws and with or without a No-profile Locking Cover, is a standalone interbody implant indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device. The interbody is intended to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone. The WaveForm A System 4-Hole No-profile Interbody may be used as a standalone device only when at least two Screws are inserted with one inferior and one superior screw trajectory. If the surgeon chooses to use the 4-Hole No-profile Interbody with fewer than two Screws inserted with one inferior and one superior screw trajectory, then additional supplemental fixation system must be used. Hyperlordotic sizes (greater than 20°) are intended for use with supplemental fixation.

No-profile Interbody Implants with Inline Fixation Anchors:

The WaveForm A System No-profile Interbody, when used with Inline Fixation Anchors and with a No-profile Locking Cover, is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device. The interbody is intended to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. The WaveForm A System No-profile Interbody with Inline Fixation Anchors is intended for use with supplemental fixation.

TruProfile Interbody Implants:

The WaveForm A System TruProfile Interbody assembled with the Anterior Plate, when used with Screws, an Anterior Plate Locking Cover, and with or without a Spin Plate, is a standalone interbody implant indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device. The interbody is intended to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. Hyperlordotic sizes (greater than 20°) are intended for use with supplemental fixation.

WaveForm C Interbody System

The WaveForm C Interbody System are interbody fusion devices intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) for multiple contiguous levels. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. These devices are to be filled with autograft bone and/or allogenic bone graft composed of cancellous, cortical, and/or corticocancellous bone or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion.

When used as a standalone system, the WaveForm C Interbody System, which includes the 2,3,4-hole TruProfile plates and 2-hole No-profile interfixated spacer, are intended to be used as an adjunct to spinal fusion procedures at multiple contiguous levels of the cervical spine (C2-T1) and must be used with bone screw fixation and locking covers.

When the WaveForm C Interbody System (excluding 2hole No-profile interfixated spacer) is used with supplemental fixation, such as anterior cervical plates, the WaveForm C Interbody System is intended to be used as an adjunct to spinal fusion procedures at multiple contiguous levels of the cervical spine (C2-T1).

WaveForm L Interbody System

Interbody Device (IBD) Implants (i.e., interbody implants used alone):

The WaveForm L Interbody System is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD, defined as back pain of discogenic origin, with degeneration of the disc confirmed by history and radiographic studies). It is intended for use at either one level or two contiguous levels in the lumbar spine, from L1 to S1, for the treatment of DDD with up to Grade 1 spondylolisthesis at the involved level(s). Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device. The interbody is intended to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion.

The WaveForm L Interbody System is intended for use as an adjunct to fusion in the thoracolumbar spine from T1 to T12 and at the thoracolumbar junction (T12-L1) for the treatment of symptomatic disc degeneration (DDD) or degenerative spondylolisthesis at one or two contiguous levels, including thoracic disc herniation (with myelopathy and/or radiculopathy with or without axial pain). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The WaveForm L Interbody System can also be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity.

The WaveForm L Interbody System is intended for use with supplemental fixation. Hyperlordotic sizes (greater than 20°) must be used with legally marketed anterior supplemental fixation.

TruProfile Interbody Implants (i.e., interbody implants used with TruProfile Plates):

The WaveForm L Interbody System assembled with the TruProfile Lateral Plate, when used with Screws, is a standalone interbody implant indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L1 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device. The interbody is intended to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. The WaveForm L Interbody System assembled with the TruProfile Lateral Plate, when used with Screws, can also be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity.

The WaveForm L Interbody System assembled with the 1-Hole TruProfile Lateral Plate, when used with a single Screw, is intended for use with additional legally marketed anterior or posterior supplemental fixation.

WaveForm TA Interbody System

When used as an intervertebral body fusion device, the system is intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous nonfusion spinal surgery at the involved spinal level(s). These patients should have had six months of non-operative treatment. The device is intended to be used with autogenous bone graft and/or allogeneic bone graft composed of cortical, cancellous, and/or corticocancellous bone or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion and supplemental fixation.

WaveForm TO Interbody System

When used as an intervertebral body fusion device, the system is intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous nonfusion spinal surgery at the involved spinal level(s). These patients should have had six months of non-operative treatment. The device is intended to be used with autogenous bone graft and/or allogeneic bone graft composed of cortical, cancellous, and/or corticocancellous bone or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion and supplemental fixation.