510(k) Report

Devices descending from K032064

1,280 later devices reach Theken Cpod/Lpod Vertebral Body Replacement System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K181644EIT Cellular Titanium® Lumbar Cage LLIFEit Emerging Implant Technologies GmbH2018141—
+6K181328T2 STRATOSPHERE™ Expandable Corpectomy SystemMedtronic Sofamor Danek USA, Inc.201828—
+6K173982FORTIFY Corpectomy SpacersGlobus Medical, Inc.20188—
+6K180215DYNA-LINK ELITE Stand-Alone Anterior Lumbar SystemLife Spine, Inc.20182—
+6K181655Renovis S180 Lateral Lumbar Interbody Fusion SystemRenovis Surgical Technologies20184—
+6K180777K2M Expandable Interbody SystemK2m, Inc.20180—
+6K180673Normandy VBR SystemZavation Medical Products, LLC20187—
+6K180695FBC 921 (Alif)Fbc Device Aps20180—
+6K181261Curiteva Cervical Interbody Fusion SystemCuriteva, LLC20184—
+6K180590Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20186—
+6K181203Juliet TiSpineart20181—
+6K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+6K180401TiWAVE-C™ Porous Titanium Cervical CageKalitec Direct, LLC20185—
+6K173189Lumfuse TPPrecifit Medical, Ltd.20180—
+6K180480ATEC Universal Spacer SystemAlphatec Spine, Inc.2018113—
+6K173722PATRIOT COLONIAL Spacer, SUSTAIN SpacerGlobus Medical, Inc.201894—
+6K173892NuVasive® XLX Interbody SystemNu Vasive, Incorporated2018115—
+6K180891EVOL Spinal Interbody System, EVOS Lumbar Interbody SystemCutting Edge Spine, LLC20181—
+6K180002Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20182—
+6K173782UNiD Patient Specific 3D printed cageMedicrea International SA201823—
+6K172947HALF DOME Posterior Lumbar Interbody SystemAstura Medical201822—
+6K180078Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF SystemInnovasis, Inc.2018551
+6K180376K2M Patient Specific RodsK2m, Inc.20182—
+6K171495Zyston Strut Open Titanium Spacer SystemZimmer Biomet Spine, Inc.20181—
+6K173025NuVasive® MLX® – Medial Lateral Expandable Lumbar Interbody System; NuVasive® AP…Nu Vasive, Incorporated20188—
+6K173702Juliet Ti LLSpineart20182—
+6K172349InFill® Interbody Fusion DevicePinnacle Spine Group, LLC20171—
+6K170389TAURUS PEEK Cage SystemMedyssey USA, Inc.20170—
+6K173030Vertera Spine Cohere Cervical Interbody Fusion DeviceNu Vasive, Incorporated201722—
+6K172253Altus Spine Cervical Interbody Fusion SystemAltus Partners, LLC20170—
+6K172083Idys™ ALIF SystemClariance, Sas20177—
+6K172437CONSTRUX® Mini PTC Spacer System, FORZA® PTC Spacer System, PILLAR® SA PTC Spacer SystemOrthofix, Inc.2017143
+6K173175Paramount Anterior Cervical Cage SystemSpine Wave, Inc.20170—
+6K172123NuVasive® Modulus XLIF Interbody SystemNu Vasive, Incorporated2017227—
+6K172199ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT…Medtronic Sofamor Danek20176—
+6K163422Shanghai Sanyou PEEK Cage SystemShanghai Sanyou Medical Co, Ltd.20173—
+6K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+6K171351Posterior Spine Truss System (PSTS) Interbody Fusion Device4Web, Inc.20177—
+6K171567IRIX-A Lumbar Integrated Fusion SystemX-Spine Systems, Inc.201701
+6K171140Matrixx SystemNexxt Spine, LLC2017145—
+6K170851Anterior Spine Truss System (STS) Interbody Fusion Device4Web, Inc.20175—
+6K171749Velofix (tm) Interbody Fusion SystemU&I Corporation20175—
+6K170676HD Lumbar Interbody SystemHd Lifesciences, LLC2017122—
+6K171031CRESCENT™ Spinal SystemMedtronic Sofamor Danek2017144—
+6K170961NuVasive CoRoent Small Interlock II SystemNu Vasive, Incorporated201718—
+6K170395Talos® Lumbar (HA) PEEK IBF DevicesMeditech Spine, LLC201710—
+6K162212Divergence-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc.201757—
+6K171097MOJAVE Expandable Interbody SystemK2m, Inc.201717—
+6K163670Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20173—
+6K162496Foundation 3D InterbodyCorelink, LLC201782—
+6K170592NuVasive BASE Interfixated Titanium SystemNu Vasive, Incorporated2017186—
+6K163581Navigated ELEVATE Inserter, Navigated Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.2017103—
+6K170643Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) SystemRti Surgical, Inc. Dba Rti Biologics201711—
+6K162680SOVEREIGN® Spinal SystemMedtronic Sofamor Danek USA, Inc.201631—
+6K162327COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL2016111—
+6K161993Leva® Anterior Interbody SystemSpine Wave, Inc.20160—
+6K162431Luna 3D Interbody Fusion SystemBenvenue Medical, Inc.20163—
+6K160924Amendia Interbody Fusion DevicesAmendia, Inc.2016166—
+6K162944Irix-C Cervical Integrated Fusion SystemX-Spine Systems, Inc.20161—
+6K162358T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution SystemSynthes USA Products, LLC2016127—
+6K161129Pillar SA PTCOrthofix, Inc.201619—
+6K160958Battalion Universal Spacer SystemAlphatec Spine2016114—
+6K160597INDEPENDENCE MIS SpacersGlobus Medical, Inc.2016111—
+6K161230NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated2016381—
+6K161028K2M Growing Spine SystemK2m, Inc.20163—
+6K161369EVEREST Spinal SystemK2m, Incorporated20169—
+6K160631Keos Lumbar IBFDKeos20161—
+6K160906Rampart O Lumbar Interbody Fusion Device, Rampart T Lumbar Interbody Fusion Device…Spineology, Inc.201627—
+6K160916CoRoent® Ti-C SystemNu Vasive, Incorporated2016139—
+6K153436LATERAL Spine Truss System4Web, Inc.20165—
+6K153419NuVasive CoRoent Thoracolumbar SystemNu Vasive, Incorporated2016400—
+6K153495Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T…Ldr Spine USA20161891
+6K152475FORZA PTC Spacer SystemOrthofix, Inc.2016236—
+6K152943NuVasive Foundation-LL SystemNu Vasive, Incorporated2015187—
+6K151773CONCORDE Bullet Lumbar Interbody SystemMedos International SARL2015201—
+6K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+6K152277PIVOX (tm) Oblique Lateral Spinal SystemMedtronic Sofamor Danek USA, Inc.2015190—
+6K143479Bluefin Interbody SystemTides Medical20152—
+6K151216Everest Spinal SystemK2m, Inc.201511—
+6K151128CAPSTONE Spinal System, CLYDESDALE Spinal SystemMedtronic Sofamor Danek USA, Inc.2015255—
+6K151374NuVasive MLX-Medial Lateral Expandable Lumbar Interbody System, NuVasive AP Expandable…Nu Vasive, Incorporated2015235—
+6K142645Avenue T TLIF CageLdr Spine USA, Inc.2015191—
+6K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+6K143616AccuLIF TL and PL CageStryker Corporation20154694
+6K141896Coroent SystemNu Vasive, Incorporated2014480—
+6K142101Abacus (TM) Spacer SystemSpine Wave, Inc.20140—
+6K142450DIVERGENCE Anterior Cervical Fusion SystemMedtronic Sofamor Danek USA, Inc.20146—
+6K133577Clydesdale (R) Spinal SystemMedtronic Sofamor Danek USA, Inc.2014256—
+6K133402K2M Modular HooksK2m, Inc.20140—
+6K133557Juliet LL Lateral Lumbar CageSpineart2014147—
+6K131276Lateral SynfixSynthes (USA) Products, LLC2014146—
+7K263049SABER-C SystemElevation Spine20260—
+7K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+7K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.20260—
+7K261810Vertiwedge® Intraosseous SystemFoundation Surgical Group20260—
+7K261430TruLift Expandable SystemLife Spine, Inc.20260—
+7K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+7K260810Anteralign LS coverplateTyber Medical, LLC20260—
+7K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, Inc.20260—
+7K260837VersaLift Expandable SystemLife Spine, Inc.20260—