510(k) Report

Devices descending from K062133

649 later devices reach Modification to Verte-Stack Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K231486Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20231—
+9K231275Exceed™ Biplanar Expandable Interbody SystemSpine Wave, Inc.20232—
+9K223418DeGen Impulse AM™ SystemDegen Medical20236—
+9K223412LumiVy™ Lumbar IBF SystemVy Spine, LLC20235—
+9K221182Southern Transforaminal Lumbar Interbody Fusion (TLIF)Southern Medical (Pty), Ltd.20220—
+9K221719ABTross ALIF Expandable Cage SystemAegis Spine, Inc.20222—
+9K213417Ghost Spacer SystemLife Spine, Inc.20220—
+9K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+9K213355Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20224—
+9K212075ShurFit Lumbar Interbody SystemPrecision Spine, Inc.20211—
+9K212070KMTI S141 Lumbar Interbody Fusion SystemKyocera Medical Technologies, Inc.20210—
+9K210574NuVasive Pulse SystemNu Vasive, Incorporated202121
+9K201755WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody SystemSeaSpine Orthopedics Corporation202017—
+9K202587ATEC Lateral Interbody SystemAlphatec Spine, Inc.202039—
+9K193418SeaSpine Skipjack SystemSeaSpine Orthopedics Corporation20204—
+9K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+9K192132SeaSpine Beachside SystemSeaSpine Orthopedics Corporation2019591
+10K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+10K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, Inc.20260—
+10K260329Ion-C Navigation InstrumentsSurGenTec, LLC20261—
+10K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+10K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+10K243816Testa TP Pivoting Spacer SystemSpine Wave, Inc.20250—
+10K243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsSeaSpine Orthopedics Corporation20250—
+10K232996Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF)Shanghai Iatrical-Ti Technologies CO, Ltd.20240—
+10K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+10K230989Rod Registration FrameNu Vasive, Incorporated20230—
+10K223474PathLoc-TA Expandable Lumbar Cage SystemL&K BIOMED Co., Ltd.20231—
+10K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+10K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+10K213420WaveForm L System, WaveForm TO System, WaveForm TA SystemSeaSpine Orthopedics Corporation202211—
+10K212540Explorer TO SystemSeaSpine Orthopedics Corporation20213—
+10K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+10K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+10K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+10K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+10K193636SeaSpine Reef TH SystemSeaSpine Orthopedics Corporation202056—
+11K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—
+11K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+11K242829BluEX Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20240—
+11K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+11K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+11K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+11K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+11K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+12K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+12K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+12K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+13K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—