510(k) Report

Devices descending from K040536

1,150 later devices reach Modification to Verte-Stack Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K171351Posterior Spine Truss System (PSTS) Interbody Fusion Device4Web, Inc.20177—
+9K172489Reliance Cervical IBF SystemReliance Medical Systems, LLC201716—
+9K171369M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20178—
+9K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+9K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc.20165—
+9K161498Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20161—
+9K161149PASS OCT Spinal SystemMedicrea International SA20160—
+9K160756PASS OCT Spinal SystemMedicrea International SA20160—
+9K153782NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated2016390—
+9K153169PASS OCT Patient Specific RodsMedicrea International20164—
+9K152211PCT SystemCentinel Spine, Inc.20150—
+9K151974Polaris Spinal SystemBiomet Spine201516—
+9K150788Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral Body Fusion…Meditech Spine, LLC2015202—
+9K150896Vitality Spinal Fixation SystemZimmer Spine, Inc.2015193
+9K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+9K150229SOLSTICE OCT SystemLife Spine, Inc.20150—
+9K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+9K140123Polaris Spinal System -Translation ScrewEbi, LLC2014221
+9K132504Tiger Occipital-Cervical-Thoracic Spinal Fixation SystemCorelink, LLC20132—
+9K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)201370—
+10K254260The VEGA Cervical Screw SystemGS Medical Co., Ltd.20260—
+10K262230Mg OSTEOREVIVE™;Mg OSTEOCRETE™Bone Solutions, Inc.20260—
+10K262489BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20260—
+10K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—
+10K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+10K261279DeltaNEC Interbody SystemNexus Spine20260—
+10K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+10K253545Vulcan Spinal SystemK2m, Inc.20260—
+10K254061Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc.20260—
+10K252711Advantage-C™ Ti3D Cervical Interbody Fusion DeviceIntelivation Technologies20260—
+10K251302OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20250—
+10K253147FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft…Prosidyan, Inc.20250—
+10K243474MagnetOs MISKuros Biosciences B.V20250—
+10K242797OsteoFlo HydroFiberSurGenTec, LLC20241—
+10K242829BluEX Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20240—
+10K230325GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal SystemGreens Surgicals Pvt., Ltd.20240—
+10K2402503D Printed PEEK Interbody SystemNvision Biomedical Technologies, Inc.20240—
+10K241564Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MISBaxter Healthcare Corporation20240—
+10K241212MagnetOs Easypack PuttyKuros Biosciences20241—
+10K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+10K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+10K240623Omnia Medical TiBrid™-SA SystemOmnia Medical, LLC20240—
+10K233966Anterior Spine Truss System-Stand Alone (ASTS-SA)4Web Medical, Inc.20241—
+10K240424Mineral Collagen Composite Bioactive Moldable Bone Graft MatrixCollagen Matrix, Inc.20240—
+10K240453ReBOSSISOrthorebirth Co., Ltd.202402
+10K234013Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20243—
+10K231715MONDRIAN™ Anterior Lumbar Plate SystemCtl Medical Corporation20240—
+10K230639Align Cervical Interbody Fusion SystemAcuity Surgical Devices, LLC20232—
+10K231836ClariVy™ Cervical IBF SystemVy Spine, LLC20232—
+10K231076VariLift®-C Interbody Fusion SystemWenzel Spine, Inc.20234—
+10K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+10K230414ClariVy™ Cervical IBF SystemVy Spine, LLC20233—
+10K223474PathLoc-TA Expandable Lumbar Cage SystemL&K BIOMED Co., Ltd.20231—
+10K223671CONDUIT LLIF Straight InsertersEnztec Limited20231—
+10K211785CASSATT™ SIJ Fixation SystemCtl Medical Corporation20220—
+10K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+10K220570M.U.S.T. MINI Posterior Cervical Screws System ExtensionMedacta International S.A.20220—
+10K213951FORZA XP Expandable Spacer SystemOrthofix US, LLC20224—
+10K212540Explorer TO SystemSeaSpine Orthopedics Corporation20213—
+10K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+10K211306LabyrinthZavation Medical Products, LLC20213—
+10K210275Polaris Spinal SystemZimmer Biomet Spine, Inc.20210—
+10K210155Duo Expandable Interbody Fusion SystemSpineology, Inc.20210—
+10K201287Impulse Interbody Fusion SystemDegen Medical20208—
+10K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc.202067—
+10K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+10K202198FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20202—
+10K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+10K201367FlareHawk TiHawk9 Interbody Fusion SystemIntegrity Implants, Inc.20202—
+10K201506Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical…Meditech Spine, LLC20200—
+10K201614TxTiHA IBF System, AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.2020471
+10K200685RIGEL 3DR Anterior Cervical Interbody Fusion SystemMiRus, LLC20200—
+10K200303Reform Pedicle Screw SystemPrecision Spine202010—
+10K200863Tiger® Occipital-Cervical-Thoracic Spinal Fixation SystemCorelink, LLC20200—
+10K193636SeaSpine Reef TH SystemSeaSpine Orthopedics Corporation202056—
+10K200130M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20206—
+10K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+10K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+10K1803473d CageFims Co., Ltd.20190—
+10K191185Solanas® Posterior OCT Fixation SystemAlphatec Spine20194—
+10K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+10K183080Mega Plus Spine SystemBk Meditech, Co., Ltd.20182—
+10K180433Ennovate®Aesculap Implant Systems, LLC201811
+10K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179—
+10K172139Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20170—
+10K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.20170—
+10K171907Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc.2017162
+10K170395Talos® Lumbar (HA) PEEK IBF DevicesMeditech Spine, LLC201710—
+10K160906Rampart O Lumbar Interbody Fusion Device, Rampart T Lumbar Interbody Fusion Device…Spineology, Inc.201627—
+10K160916CoRoent® Ti-C SystemNu Vasive, Incorporated2016139—
+10K150856Reform Pedicle Screw SystemPrecision Spine, Inc.201526—
+10K141804Polaris Spinal System - HA CoatedBiomet Spine, LLC201421—
+11K262025Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis…INNO Holdings Inc. DBA Innovasis20260—
+11K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.20260—
+11K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+11K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+11K251522Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20251—
+11K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+11K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+11K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—