510(k) Report

Devices descending from K024364

1,683 later devices reach Synthes Vertebral Spacer TI (Curved and Narrow) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K212715Vy Spine ClariVy Cervical IBF SystemVy Spine, LLC20216—
+8K213115CHENA-C Spacer SystemKahtnu Surgical, Inc.20210—
+8K212653Catalyft LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.202127
+8K211689KEYSTONE PEEK Cage SystemShanghai Sanyou Medical Co, Ltd.20212—
+8K212540Explorer TO SystemSeaSpine Orthopedics Corporation20213—
+8K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+8K211442StealthStation Spinous Process ClampsMedtronic Navigation20212—
+8K200919Idys ALIF 3DTiClariance20210—
+8K210155Duo Expandable Interbody Fusion SystemSpineology, Inc.20210—
+8K203531XYPAN Expandable Lumbar Cage SystemAegis Spine, Inc.20213—
+8K202298Lucent XP, Lucent XP CurvedSpinal Elements, Inc.20202—
+8K202587ATEC Lateral Interbody SystemAlphatec Spine, Inc.202039—
+8K201605EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF Cage, EIT Cellular…Eit Emerging Implant Technologies GmbH2020130—
+8K200920Idys ALIF ZP 3DTiClariance, Sas20203—
+8K200991EVOL Spinal Interbody SystemCutting Edge Spine, LLC20200—
+8K193636SeaSpine Reef TH SystemSeaSpine Orthopedics Corporation202056—
+8K200552EVOS Lumbar Interbody SystemCutting Edge Spine, LLC20200—
+8K193506NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR SystemNu Vasive, Incorporated20201—
+8K193255Largo PEEK Interbody SystemFlospine, LLC20201—
+8K193521Steerable Plateau TiLife Spine, Inc.20201—
+8K193258ProLift Expandable SystemLife Spine, Inc.20203—
+8K1920444CIS Marlin PEEK ACIF CageSolco Biomedical Co., Ltd.20190—
+8K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+8K190721LongBow TiLife Spine, Inc.20190—
+8K192582NuVasive CoRoent Small Interlock SystemNu Vasive, Incorporated201930—
+8K192168Idys ALIF ZP 3DTiClariance, Sas20195—
+8K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+8K191584FORTICO Anterior Cervical Fixation SystemCamber Spine Technologies, LLC20192—
+8K191039Navigated T2 STRATOSPHERE Inserters and Navigated TemplatesMedtronic Sofamor Danek USA, Inc.201918—
+8K192047Rampart™ One Lumbar Interbody Fusion SystemSpineology, Inc.20190—
+8K190959ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2019108—
+8K183064TxTi IBF SystemInnovasis, Inc.2019481
+8K182608Oyster ACIF CageSilony Medical GmbH20190—
+8K191263Idys ALIF TiVacClariance, Sas20190—
+8K190655SeaSpine® Shoreline™ ACS- Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation201974—
+8K181625Life Spine Resolute™ Threaded Cage SystemLife Spine, Inc.20180—
+8K181531SpineEX Sagittae Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20183—
+8K181453ATEC ALIF Spacer SystemAlphatec Spine, Inc.2018111—
+8K181203Juliet TiSpineart20181—
+8K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+8K173189Lumfuse TPPrecifit Medical, Ltd.20180—
+8K180891EVOL Spinal Interbody System, EVOS Lumbar Interbody SystemCutting Edge Spine, LLC20181—
+8K172947HALF DOME Posterior Lumbar Interbody SystemAstura Medical201822—
+8K180376K2M Patient Specific RodsK2m, Inc.20182—
+8K173128Alamo® CAlliance Partners, LLC20182—
+8K180431Cortina [MAX] Lumbar Cage SystemNeurostructures, Inc.20181—
+8K171495Zyston Strut Open Titanium Spacer SystemZimmer Biomet Spine, Inc.20181—
+8K172828Double Medical Cage SystemDouble Medical Technology, Inc.20181—
+8K171434ROCCIA® MultiLIFSilony Medical GmbH20174—
+8K172756Varian cageMedyssey USA, Inc.20171—
+8K173030Vertera Spine Cohere Cervical Interbody Fusion DeviceNu Vasive, Incorporated201722—
+8K173175Paramount Anterior Cervical Cage SystemSpine Wave, Inc.20170—
+8K172199ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT…Medtronic Sofamor Danek20176—
+8K163422Shanghai Sanyou PEEK Cage SystemShanghai Sanyou Medical Co, Ltd.20173—
+8K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+8K170919The TiBow Expandable Spacer SystemLife Spine, Inc.20171—
+8K171749Velofix (tm) Interbody Fusion SystemU&I Corporation20175—
+8K171031CRESCENT™ Spinal SystemMedtronic Sofamor Danek2017144—
+8K170962NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated2017304—
+8K170961NuVasive CoRoent Small Interlock II SystemNu Vasive, Incorporated201718—
+8K170395Talos® Lumbar (HA) PEEK IBF DevicesMeditech Spine, LLC201710—
+8K162212Divergence-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc.201757—
+8K163670Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20173—
+8K163707NuVasive CoRoent Ti-C SystemNu Vasive, Incorporated201719—
+8K163581Navigated ELEVATE Inserter, Navigated Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.2017103—
+8K170512Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC20176—
+8K163543Biomet Fusion SystemZimmer Biomet Spine, Inc.2017124—
+8K162680SOVEREIGN® Spinal SystemMedtronic Sofamor Danek USA, Inc.201631—
+8K162944Irix-C Cervical Integrated Fusion SystemX-Spine Systems, Inc.20161—
+8K160074Rampart D Lumbar Interbody Fusion DeviceSpineology, Inc.20165—
+8K161028K2M Growing Spine SystemK2m, Inc.20163—
+8K161369EVEREST Spinal SystemK2m, Incorporated20169—
+8K160631Keos Lumbar IBFDKeos20161—
+8K160906Rampart O Lumbar Interbody Fusion Device, Rampart T Lumbar Interbody Fusion Device…Spineology, Inc.201627—
+8K153517AnyPlus® Cervical PEEK Cage SystemGS Medical Co., Ltd.201612—
+8K153436LATERAL Spine Truss System4Web, Inc.20165—
+8K153629ArcadiusXP C Spinal SystemAesculap Implant Systems, Inc.20167—
+8K153783SpaceVision® PLIF, SpaceVision® OLIF, SpaceVision® TLIFSpinevision S.A.201613—
+8K153250Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies201632—
+8K160418PERIMETER Interbody Fusion DeviceMedtronic Sofamor Danek USA, Inc.20165—
+8K151406Cogent Lateral Interbody SystemCogent Spine, LLC201611—
+8K152620Spine Wave Gen II Expandable Interbody SystemSpine Wave, Inc.20162—
+8K151773CONCORDE Bullet Lumbar Interbody SystemMedos International SARL2015201—
+8K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+8K152277PIVOX (tm) Oblique Lateral Spinal SystemMedtronic Sofamor Danek USA, Inc.2015190—
+8K151216Everest Spinal SystemK2m, Inc.201511—
+8K151128CAPSTONE Spinal System, CLYDESDALE Spinal SystemMedtronic Sofamor Danek USA, Inc.2015255—
+8K151374NuVasive MLX-Medial Lateral Expandable Lumbar Interbody System, NuVasive AP Expandable…Nu Vasive, Incorporated2015235—
+8K150231Navigated Disc Prep Instruments and CAPSTONE TrialsMedtronic Sofamor Danek USA, Inc.2015242—
+8K142645Avenue T TLIF CageLdr Spine USA, Inc.2015191—
+8K150954Elite L Expandable Lumbar Fusion SystemInnova Spinal Technologies, LLC20156—
+8K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+8K143616AccuLIF TL and PL CageStryker Corporation20154694
+8K141187Impix Alif S/aMedicrea International SA201501
+8K141896Coroent SystemNu Vasive, Incorporated2014480—
+8K142101Abacus (TM) Spacer SystemSpine Wave, Inc.20140—
+8K142193Cogent Med-Lif XLCogent Spine, LLC201412—
+8K142450DIVERGENCE Anterior Cervical Fusion SystemMedtronic Sofamor Danek USA, Inc.20146—
+8K133577Clydesdale (R) Spinal SystemMedtronic Sofamor Danek USA, Inc.2014256—
+8K1421124WEB Spinal Implant Products4Web, Inc.201433—