510(k) Report

Devices descending from K040422

1,002 later devices reach Modification to Verte-Stack through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K173260SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica…SeaSpine Orthopedics Corporation201767—
+9K173522Solanas® Posterior Stabilization SystemAlphatec Spine, Inc.20175—
+9K172392Lateral Spinal Truss System (LSTS) Interbody Fusion Device4Web, Inc.20171—
+9K171686Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) SystemChoicespine2017116—
+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—
+9K153169PASS OCT Patient Specific RodsMedicrea International20164—
+9K152211PCT SystemCentinel Spine, Inc.20150—
+9K151974Polaris Spinal SystemBiomet Spine201516—
+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—
+10K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+10K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+10K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+10K261279DeltaNEC Interbody SystemNexus Spine20260—
+10K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, Inc.20260—
+10K253894BMD Titanium Spinal Fusion SystemGlobal Biomedica s.r.o.20260—
+10K260329Ion-C Navigation InstrumentsSurGenTec, LLC20261—
+10K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+10K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+10K253545Vulcan Spinal SystemK2m, Inc.20260—
+10K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, 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—
+10K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+10K253377Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc.20250—
+10K253147FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft…Prosidyan, Inc.20250—
+10K243816Testa TP Pivoting Spacer SystemSpine Wave, Inc.20250—
+10K251003X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+10K243474MagnetOs MISKuros Biosciences B.V20250—
+10K250602X-PAC® N-GAGE™ Lumbar Plate SystemExpanding Innovations, Inc.20250—
+10K243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsSeaSpine Orthopedics Corporation20250—
+10K242797OsteoFlo HydroFiberSurGenTec, LLC20241—
+10K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+10K230325GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal SystemGreens Surgicals Pvt., Ltd.20240—
+10K241477aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20246—
+10K233807LumiVy™ Lumbar IBF SystemVy Spine, LLC20241—
+10K241332aprevo® anterior and lateral lumbar interbody fusion device; aprevo® anterior lumbar…Carlsmed, Inc.20245—
+10K2402503D Printed PEEK Interbody SystemNvision Biomedical Technologies, Inc.20240—
+10K232996Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF)Shanghai Iatrical-Ti Technologies CO, Ltd.20240—
+10K241328aprevo® Anterior and Lateral Lumbar Interbody Fusion device (ALIF/LLIF); aprevo®…Carlsmed, Inc.20240—
+10K241564Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MISBaxter Healthcare Corporation20240—
+10K241019aprevo® TLIF-C Articulating SystemCarlsmed20244—
+10K241212MagnetOs Easypack PuttyKuros Biosciences20241—
+10K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+10K240623Omnia Medical TiBrid™-SA SystemOmnia Medical, LLC20240—
+10K233966Anterior Spine Truss System-Stand Alone (ASTS-SA)4Web Medical, Inc.20241—
+10K232282aprevo® anterior and lateral lumbar interbody fusion device, aprevo® transforaminal…Carlsmed, Inc.20240—
+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—
+10K233594Genesys Spine 3DP AIS-C II Cervical Interbody SystemGenesys Spine20232—
+10K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+10K230639Align Cervical Interbody Fusion SystemAcuity Surgical Devices, LLC20232—
+10K231836ClariVy™ Cervical IBF SystemVy Spine, LLC20232—
+10K232822Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system), Anterior…Gbs Commonwealth Co., Ltd.20232—
+10K231076VariLift®-C Interbody Fusion SystemWenzel Spine, Inc.20234—
+10K223869ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20232—
+10K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+10K231140aprevo® transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20236—
+10K230414ClariVy™ Cervical IBF SystemVy Spine, LLC20233—
+10K230989Rod Registration FrameNu Vasive, Incorporated20230—
+10K221324ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)Camber Spine Technologies20230—
+10K223412LumiVy™ Lumbar IBF SystemVy Spine, LLC20235—
+10K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+10K221719ABTross ALIF Expandable Cage SystemAegis Spine, Inc.20222—
+10K213417Ghost Spacer SystemLife Spine, Inc.20220—
+10K220953ChoiceSpine TigerShark™ M, Modular Interbody SystemChoice Spine, LLC20220—
+10K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+10K220570M.U.S.T. MINI Posterior Cervical Screws System ExtensionMedacta International S.A.20220—
+10K220096Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20220—
+10K212980Tesera-k ALIF SystemKyocera Medical Technologies, Inc.20222—
+10K213951FORZA XP Expandable Spacer SystemOrthofix US, LLC20224—
+10K211449Triton™ Sacroiliac Joint Fixation SystemChoice Spine, LLC20211—
+10K210090Impulse AM Interbody Fusion SystemDegen Medical20217—
+10K211388Lateral Spine Truss System (LSTS) Interbody Fusion Device4Web Medical, Inc.20210—
+10K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+10K210542aprevo Transforaminal IBFCarlsmed, Inc.202112—
+10K211306LabyrinthZavation Medical Products, LLC20213—
+10K210275Polaris Spinal SystemZimmer Biomet Spine, Inc.20210—
+10K210155Duo Expandable Interbody Fusion SystemSpineology, Inc.20210—
+10K201643ChoiceSpine Tiger Shark Cervical Spacer SystemChoice Spine, LLC20204—
+10K201287Impulse Interbody Fusion SystemDegen Medical20208—
+10K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc.202067—
+10K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—