510(k) Report

Devices descending from K040928

1,504 later devices reach Expandable Peek VBR Implant through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K180556Corelink Foundation 3D Anterior Lumbar SystemCorelink, LLC20185—
+7K180963Roccia Alif, Roccia TlifSilony Medical GmbH20183—
+7K181246Zavation IBF SystemZavation Medical Products, LLC201822—
+7K181261Curiteva Cervical Interbody Fusion SystemCuriteva, LLC20184—
+7K173347STALIF C FLX, STALIF M FLX, STALIF L FLX and STALIF Lateral-Oblique FLX, ACTILIF C FLX…Centinel Spine, Inc.201812—
+7K180437Hexanium® TLIFSpinevision, S.A.S.20182—
+7K173892NuVasive® XLX Interbody SystemNu Vasive, Incorporated2018115—
+7K180431Cortina [MAX] Lumbar Cage SystemNeurostructures, Inc.20181—
+7K173535Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TAS Hyperlordotic Interbody…Titan Spine, LLC20181052
+7K172926SeaSpine Vu cPOD, Zuma-C, Complete CervicalSeaSpine Orthopedics Corporation201761—
+7K171848FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO…Globus Medical, Inc.201755—
+7K173182ProLift® Expandable SystemLife Spine, Inc.201737—
+7K172888EIT Cellular Titanium® Cervical Cages, EIT Cellular Titanium® PLIF Cages, EIT Cellular…Eit Emerging Implant Technologies GmbH2017159—
+7K172446SPIRA-C Open Matrix Cervical InterbodyCamber Spine Technologies20176—
+7K172437CONSTRUX® Mini PTC Spacer System, FORZA® PTC Spacer System, PILLAR® SA PTC Spacer SystemOrthofix, Inc.2017143
+7K171633NuVasive TLX Interbody SystemNu Vasive, Incorporated2017251—
+7K171567IRIX-A Lumbar Integrated Fusion SystemX-Spine Systems, Inc.201701
+7K171660Duo Lumbar Interbody Fusion DeviceSpineology, Inc.20174—
+7K171630LumFuse-TPPrecifit Medical, Ltd.20171—
+7K163506Coalesce™ (-Straight, -Convex, -Crescent, -Lateral, -Anterior, or -Oblique) Lumbar…Vertera, Inc.2017224—
+7K162760Spine Wave Anterior Cervical Spine SystemSpine Wave, Inc.20171—
+7K162918Atlas Spine Expandable Interbody SystemAtlas Spine, Inc.201729—
+7K161127The Small PLATEAU (PLATEAU-C) Spacer SystemLife Spine, Inc.20166—
+7K162327COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL2016111—
+7K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation201679—
+7K162431Luna 3D Interbody Fusion SystemBenvenue Medical, Inc.20163—
+7K161173Avenue® T TLIF CageLdr Spine USA, Inc.20163—
+7K160066Pro-Link® Stand-Alone Cervical Spacer SystemLife Spine, Inc.20163—
+7K160597INDEPENDENCE MIS SpacersGlobus Medical, Inc.2016111—
+7K161405Valeo II Interbody Fusion Device SystemAmedica Corp.20164—
+7K161210RIALTO (TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC (TM)…Medtronic Sofamor Danek201679—
+7K160605MectaLIF Anterior Stand-AloneMedacta International201610—
+7K161223TransContinental® M Spacers and InterContinental® Plate-SpacersGlobus Medical, Inc.2016117—
+7K153786Prow Fusion-VNlt Spine, Ltd.20166—
+7K153105MLX™ - Medial Lateral Expandable Lumbar Interbody SystemNu Vasive, Incorporated2016234—
+7K160154ALTA Anterior Cervical Interbody SpacerAstura Medical201663—
+7K160051NuVasive® Interfixated Interbody SystemNu Vasive, Incorporated2016396—
+7K153495Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T…Ldr Spine USA20161891
+7K153782NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated2016390—
+7K153627NuVasive® TLX Interbody SystemNu Vasive, Incorporated2016252—
+7K151406Cogent Lateral Interbody SystemCogent Spine, LLC201611—
+7K160291Optimus ALIF SystemAmendia, Inc.20160—
+7K153442CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with…Medtronic Sofamor Danek USA, Inc.201684—
+7K152972Amendia Stand-Alone Cervical SystemAmendia, Inc.201632
+7K152355Twin Peaks Lumbar Interbody Fusion SystemSpineway20151—
+7K151773CONCORDE Bullet Lumbar Interbody SystemMedos International SARL2015201—
+7K152259InFill Interbody Fusion DevicePinnacle Spine Group, LLC20152—
+7K151472NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated2015479—
+7K151322Amendia Interbody Fusion DevicesAmendia, Inc.20152261
+7K151140LnK Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.201529—
+7K151677LnK Cervical Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20158—
+7K150994NuVasive CoRoent Thoracolumbar ImplantsNu Vasive, Incorporated2015402—
+7K143595NuVasive (R) CCX-L Interbody SystemNu Vasive, Incorporated2015253—
+7K143616AccuLIF TL and PL CageStryker Corporation20154694
+7K143228Ancora LLC Interbody Fusion DeviceFrontier Medical Devices, Inc.20150—
+7K143163AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK Spacer…Stryker Corporation2015636—
+7K141896Coroent SystemNu Vasive, Incorporated2014480—
+7K142347Amedica Valeo II Interbody Fusion DeviceAmedica Corp.20145—
+7K142066Aero-LL Lumbar Cage SystemStryker Corporation20142—
+7K141942Midline II TICentinel Spine, Inc.2014459—
+7K141953Endoskeleton; TA Ibd and VBR, to and TT, Tas, TC, TLTitan Spine, LLC20142652
+7K142589Endoskeleton TA IBD and VBR, Endoskeleton TO and TT, Endoskeleton TAS, Endoskeleton TAS…Titan Spine, LLC2014106—
+7K142193Cogent Med-Lif XLCogent Spine, LLC201412—
+7K133577Clydesdale (R) Spinal SystemMedtronic Sofamor Danek USA, Inc.2014256—
+7K1421124WEB Spinal Implant Products4Web, Inc.201433—
+7K140479Coroent XL-F SystemNu Vasive, Incorporated2014465—
+7K140529Everest Spinal SystemK2m, LLC201431—
+7K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+7K131276Lateral SynfixSynthes (USA) Products, LLC2014146—
+7K132757Everest Spinal SystemK2m, Inc.201341—
+7K131669Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek USA, Inc.2013234—
+7K132361Everest Spinal SystemK2m, Inc.201334—
+7K131077Life Spine Plateau Spacer SystemLife Spine201310—
+7K130445Vault Alif SystemSpinal USA20139—
+7K123281Acculif TL-Peek CageCoalign Innovations, Inc.2013146—
+7K123752Acculif TL and PL CageCoalign Innovations, Inc.2013676—
+7K121649Construx Mini Peek TI Spacer SystemOrthofix2012289—
+7K111166A-Wedge Anterior Interbody System (a-Wedge a.I.S.)Spineworks, LLC201123—
+7K111122Aesculap Sibd XP Spinal SystemAesculap Implant Systems, Inc.2011460—
+7K111675VU C*Pod Intervertebral Body Fusion DeviceTheken Spine, LLC201162—
+7K111835Plateau Spacer SystemLife Spine, Inc.2011120—
+7K102547Coroent Interlock SystemNuvasive, Inc.2011131—
+7K101310VU Apod Intervertebral Body Fusion DeviceTheken Spine, LLC2010480—
+8K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+8K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+8K263049SABER-C SystemElevation Spine20260—
+8K262025Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis…INNO Holdings Inc. DBA Innovasis20260—
+8K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—
+8K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+8K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+8K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+8K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+8K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+8K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+8K253604TiLink-L Navigation InstrumentsSurGenTec, LLC20260—
+8K253748Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer SystemLife Spine, Inc.20260—
+8K252322SIros-X SystemGenesys Spine20250—
+8K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+8K251444Endoskeleton™ Interbody SystemsMedtronic Sofamor Danek USA, Inc.20250—
+8K250247panaSIa SI Fusion SystemWenzel Spine, Inc.20250—