510(k) Report

Devices descending from K802462

696 later devices reach Synthes Spinal Implant System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K051039Basis Spinal SystemMedtronic Sofamor Danek USA, Inc.20050—
+1K042499Orion Anterior Cervical Plating SystemMedtronic Sofamor Danek2004694—
+2K141332Captiva Spine SmartLOX Cervical Plate SystemCaptiva Spine20151—
+2K101848Sapphire Anterior Cervical Plate SystemSpinal Elements, Inc.20102—
+2K100265Diamond Anterior Cervical Plate SystemAmendia, Inc.201034—
+2K042922Venture Anterior Cervical Plating SystemMedtronic Sofamor Danek, Inc.2004677—
+3K200301UNiTi ACDF Implant SystemPressio, Inc.20210—
+3K202972Anterior Cervical Plate SystemNutech Spine and Biologics20200—
+3K201029Sapphire® Spinal System, Sapphire X Anterior Cervical Plate Spinal SystemSpinal Elements, Inc.20201—
+3K182885Atlantis™ Anterior Cervical Plate, Divergence™ Anterior Cervical Fusion System, Premier™…Medtronic Sofamor Danek USA, Inc.20198—
+3K171797TRYPTIK2 C-Plate Anterior Cervical Plate SystemSpineart20180—
+3K113329K2M, Pyrenees Cervical Plate SystemK2m, Inc.201228—
+3K100215Archimed Remedy Cervical PlateArchimed, Inc.20100—
+3K071033T2 XVBR Spinal SystemMedtronic Sofamor Danek200750—
+3K061274Venture Anterior Cervical Plate SystemMedtronic Sofamor Danek2006669—
+4K231593Sapphire X3 Anterior Cervical Plate SystemSpinal Elements, Inc.20230—
+4K223321Omnia Medical Coupler-C Anterior Cervical PlateOmnia Medical, LLC20230—
+4K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+4K191584FORTICO Anterior Cervical Fixation SystemCamber Spine Technologies, LLC20192—
+4K183510T2 STRATOSPHERE Expandable Corpectomy SystemMedtronic Sofamor Danek USA, Inc.201927—
+4K182473PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System, OZARK Cervical Plate…K2m, Inc.20184—
+4K173125T2 STRATOSPHERE™ Expandable Corpectomy SystemMedtronic Sofamor Danek201747—
+4K140234Aspiron Acp SystemU&I Corp.20146—
+4K130202Iris Anterior Cervical PlateLife Spine, Inc.201321—
+4K121862Rex Anterior Cervical Plate SystemDio Medical Co., Ltd.20127—
+4K102820Appliance, Fixation, Spinal Intervertebral BodyAlphatec Spine, Inc.2010382
+4K100976T2 XVBR 1.5 Spinal SystemMedtronic Sofamor Danek USA, Inc.201049—
+4K073285Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek USA, Inc.2008637—
+5K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+5K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+5K241164IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic)202412
+5K231251FlexWing Anterior Cervical Plate SystemJeil Medical Corporation20242—
+5K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+5K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+5K221728Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran™ Anterior…Stryker Corporation20221—
+5K222572FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, and…Dio Medical Corporation20222—
+5K210470C-CURVE Interbody Fusion DeviceMedicrea International SA20210—
+5K211205Prase-C Anterior Cervical Plate SystemGbs Commonwealth Co., Ltd.20210—
+5K200995Insignia™ Anterior Cervical Plate SystemAlphatec Spine, Inc.2020729
+5K191066CD Horizon™ Astute™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201921—
+5K191039Navigated T2 STRATOSPHERE Inserters and Navigated TemplatesMedtronic Sofamor Danek USA, Inc.201918—
+5K190053SECULOK™ ACP SystemU&I Corporation20191—
+5K181328T2 STRATOSPHERE™ Expandable Corpectomy SystemMedtronic Sofamor Danek USA, Inc.201828—
+5K182055SECULOK™ ACP SystemU&I Corporation20182—
+5K173099Fortis and Hana Anterior Cervical Plate SystemHuvexel Co., Ltd.20174—
+5K163104Terrace™ Anterior Cervical Plate SystemCorelink, LLC201718—
+5K162531Sterispine CCSafe Orthopaedics20160—
+5K153373CORNERSTONE PSR Cervical Fusion System, PERIMETER C Spinal System, PEEK PREVAIL Cervical…Medtronic Sofamor Danek2016110—
+5K152282Cam Lock Plating SystemLife Spine, Inc.20151—
+5K152193Renovis Anterior Cervical Plate SystemRenovis Surgical Technologies, Inc.20154—
+5K142218Coalition AGX Plate and Coalition AGX SpacerGlobus Medical, Inc.2015155—
+5K142940Endoskeleton TCS SystemTitan Spine, LLC20151112
+5K133494Chesapeake Spinal SystemK2m, Inc.2014330—
+5K131888T2 XVBR Spinal System, T2 Altitude Expandable Corpectomy DeviceMedtronic Sofamor Danek, Inc.20130—
+5K132366Spinal Intervertebral Body Fixation OrthosisAccel Spine20130—
+5K131520Nexus Anterior Cervical Plate SystemCore-Nexus20130—
+5K122037Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion System Peek Prevail…Medtronic Sofamor Danek, Inc.2013281—
+5K120275Synthes Acis/Vertebral Spacer CRSynthes (Usa), LLC2012173—
+5K112459Synthes Zero-PSynthes Spine Co.Lp2011277—
+5K111132Genesys Spine Anterior Cervical Plate SystemGenesys Spine201141
+5K112068Synthes Zero-P Variable Angle (VA)Synthes Spine Co.Lp2011331
+5K100967Perimeter C Spinal SystemMedtronic Sofamor Danek USA, Inc.2011121—
+5K103137Venus Anterior Cervical PlateVerticor, Ltd.20115—
+5K102323Cervical Standalone Intervertebral Body Fusion DeviceTheken Spine, LLC201062—
+5K094042Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek2010397—
+5K100214Cornerstone PSR Cervical Interbody Fusion DeviceMedtronic Sofamor Danek2010389—
+6K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+6K253213SAGI Cervical Cage SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+6K253545Vulcan Spinal SystemK2m, Inc.20260—
+6K253577IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)Medicrea International S.A.S. (Medtronic)20250—
+6K252826ARIX Femur Nail SystemJeil Medical Corporation20250—
+6K250764SpineLinc Anterior Cervical Implant SystemLincotek Medical20250—
+6K250769Dakota LP SystemPrecision Spine, Inc.20250—
+6K250446Frida™ Anterior Cervical Plate SystemSpineup, Inc.20250—
+6K243369Cervical Plating SystemLife Spine, Inc.20240—
+6K242195Gemini Cervical Fusion Cage SystemZheJiang Decans Medical Devices Co., Ltd.20241—
+6K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue®…Lesspine Innovations20230—
+6K231739Cervical Spine Truss System (CSTS)4Web Medical, Inc.20232—
+6K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+6K231460FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System…K&J Consulting Corp.20230—
+6K230424Omnia Medical Coupler-A™ Anterior Lumbar Plate System; Omnia Medical Coupler-L™ Lateral…Omnia Medical, LLC20230—
+6K220334MONET Anterior Cervical Plate SystemCtl Medical Corporation20220—
+6K221646CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™…Medtronic Sofamor Danek USA, Inc.202220—
+6K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+6K220379IMPEACE and IMPEACE-Uni Anterior Cervical Plate SystemMedynus, Inc.20220—
+6K220147Aspiron S ACP SystemU&I Corporation20220—
+6K212266FIX-C PEEK Anterior Cervical Interbody SystemJeil Medical Corporation20217—
+6K213443Insignia™ Anterior Cervical Plate SystemAlphatec Spine, Inc.20216—
+6K200458Tailored-C Cervical Interbody Fusion SystemBespoke Technologies20203—
+6K193494Origin™ Anterior Cervical Plate SystemOrthopaedic & Spine Development20200—
+6K192906Mecta-C Stand AloneMedacta International S.A.20201—
+6K192336Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.201917—
+6K192208CORNICE Cervical Spacer SystemLegend Spine Technologies20190—
+6K191243HEDRON Cervical SpacersGlobus Medical, Inc.201936—
+6K190885Elevation Spine Saber-C SystemElevation Spine201925—
+6K191565Endoskeleton TCS Interbody Fusion DeviceTitan Spine, Inc.201901
+6K190016Lateral Plate SystemCorelink, LLC201915—
+6K180909REVEL SpacersGlobus Medical, Inc.201837—
+6K181140Axis Chena Cervical PEEK Spacer SystemAxis Orthopaedics20182—
+6K181229TirboLOX-C Cervical IBFDCaptiva Spine, Inc.20180—