510(k) Report

Devices descending from K043561

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K171686Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) SystemChoicespine2017116—
+8K171351Posterior Spine Truss System (PSTS) Interbody Fusion Device4Web, Inc.20177—
+8K172489Reliance Cervical IBF SystemReliance Medical Systems, LLC201716—
+8K171369M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20178—
+8K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+8K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc.20165—
+8K161498Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20161—
+8K161149PASS OCT Spinal SystemMedicrea International SA20160—
+8K160756PASS OCT Spinal SystemMedicrea International SA20160—
+8K153169PASS OCT Patient Specific RodsMedicrea International20164—
+8K152211PCT SystemCentinel Spine, Inc.20150—
+8K151974Polaris Spinal SystemBiomet Spine201516—
+8K150896Vitality Spinal Fixation SystemZimmer Spine, Inc.2015193
+8K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+8K150229SOLSTICE OCT SystemLife Spine, Inc.20150—
+8K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+8K140123Polaris Spinal System -Translation ScrewEbi, LLC2014221
+8K132504Tiger Occipital-Cervical-Thoracic Spinal Fixation SystemCorelink, LLC20132—
+8K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)201370—
+9K254260The VEGA Cervical Screw SystemGS Medical Co., Ltd.20260—
+9K262230Mg OSTEOREVIVE™;Mg OSTEOCRETE™Bone Solutions, Inc.20260—
+9K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+9K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+9K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+9K261279DeltaNEC Interbody SystemNexus Spine20260—
+9K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, Inc.20260—
+9K253894BMD Titanium Spinal Fusion SystemGlobal Biomedica s.r.o.20260—
+9K260329Ion-C Navigation InstrumentsSurGenTec, LLC20261—
+9K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+9K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+9K253545Vulcan Spinal SystemK2m, Inc.20260—
+9K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+9K254061Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc.20260—
+9K252711Advantage-C™ Ti3D Cervical Interbody Fusion DeviceIntelivation Technologies20260—
+9K251302OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20250—
+9K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+9K253377Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc.20250—
+9K253147FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft…Prosidyan, Inc.20250—
+9K243816Testa TP Pivoting Spacer SystemSpine Wave, Inc.20250—
+9K251003X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+9K243474MagnetOs MISKuros Biosciences B.V20250—
+9K250602X-PAC® N-GAGE™ Lumbar Plate SystemExpanding Innovations, Inc.20250—
+9K243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsSeaSpine Orthopedics Corporation20250—
+9K242797OsteoFlo HydroFiberSurGenTec, LLC20241—
+9K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+9K230325GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal SystemGreens Surgicals Pvt., Ltd.20240—
+9K241477aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20246—
+9K233807LumiVy™ Lumbar IBF SystemVy Spine, LLC20241—
+9K241332aprevo® anterior and lateral lumbar interbody fusion device; aprevo® anterior lumbar…Carlsmed, Inc.20245—
+9K2402503D Printed PEEK Interbody SystemNvision Biomedical Technologies, Inc.20240—
+9K232996Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF)Shanghai Iatrical-Ti Technologies CO, Ltd.20240—
+9K241328aprevo® Anterior and Lateral Lumbar Interbody Fusion device (ALIF/LLIF); aprevo®…Carlsmed, Inc.20240—
+9K241564Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MISBaxter Healthcare Corporation20240—
+9K241019aprevo® TLIF-C Articulating SystemCarlsmed20244—
+9K241212MagnetOs Easypack PuttyKuros Biosciences20241—
+9K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+9K240623Omnia Medical TiBrid™-SA SystemOmnia Medical, LLC20240—
+9K233966Anterior Spine Truss System-Stand Alone (ASTS-SA)4Web Medical, Inc.20241—
+9K232282aprevo® anterior and lateral lumbar interbody fusion device, aprevo® transforaminal…Carlsmed, Inc.20240—
+9K240424Mineral Collagen Composite Bioactive Moldable Bone Graft MatrixCollagen Matrix, Inc.20240—
+9K240453ReBOSSISOrthorebirth Co., Ltd.202402
+9K234013Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20243—
+9K231715MONDRIAN™ Anterior Lumbar Plate SystemCtl Medical Corporation20240—
+9K233594Genesys Spine 3DP AIS-C II Cervical Interbody SystemGenesys Spine20232—
+9K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+9K230639Align Cervical Interbody Fusion SystemAcuity Surgical Devices, LLC20232—
+9K231836ClariVy™ Cervical IBF SystemVy Spine, LLC20232—
+9K232822Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system), Anterior…Gbs Commonwealth Co., Ltd.20232—
+9K231076VariLift®-C Interbody Fusion SystemWenzel Spine, Inc.20234—
+9K223869ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20232—
+9K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+9K231140aprevo® transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20236—
+9K230414ClariVy™ Cervical IBF SystemVy Spine, LLC20233—
+9K230989Rod Registration FrameNu Vasive, Incorporated20230—
+9K221324ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)Camber Spine Technologies20230—
+9K223412LumiVy™ Lumbar IBF SystemVy Spine, LLC20235—
+9K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+9K221719ABTross ALIF Expandable Cage SystemAegis Spine, Inc.20222—
+9K213417Ghost Spacer SystemLife Spine, Inc.20220—
+9K220953ChoiceSpine TigerShark™ M, Modular Interbody SystemChoice Spine, LLC20220—
+9K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+9K220570M.U.S.T. MINI Posterior Cervical Screws System ExtensionMedacta International S.A.20220—
+9K220096Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20220—
+9K212980Tesera-k ALIF SystemKyocera Medical Technologies, Inc.20222—
+9K213951FORZA XP Expandable Spacer SystemOrthofix US, LLC20224—
+9K211449Triton™ Sacroiliac Joint Fixation SystemChoice Spine, LLC20211—
+9K210090Impulse AM Interbody Fusion SystemDegen Medical20217—
+9K211388Lateral Spine Truss System (LSTS) Interbody Fusion Device4Web Medical, Inc.20210—
+9K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+9K210542aprevo Transforaminal IBFCarlsmed, Inc.202112—
+9K211306LabyrinthZavation Medical Products, LLC20213—
+9K210275Polaris Spinal SystemZimmer Biomet Spine, Inc.20210—
+9K210155Duo Expandable Interbody Fusion SystemSpineology, Inc.20210—
+9K201643ChoiceSpine Tiger Shark Cervical Spacer SystemChoice Spine, LLC20204—
+9K201287Impulse Interbody Fusion SystemDegen Medical20208—
+9K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc.202067—
+9K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+9K202198FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20202—
+9K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+9K201939GAIA Lumbar Interbody Fusion Device (LIFD) FamilyPrinterprezz20200—