510(k) Report

Devices descending from K041722

1,150 later devices reach Modification to VBR Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K163366Shanghai Sanyou CARMEN Cervical Fusion SystemShanghai Sanyou Medical Co, Ltd.20170—
+5K172199ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT…Medtronic Sofamor Danek20176—
+5K171351Posterior Spine Truss System (PSTS) Interbody Fusion Device4Web, Inc.20177—
+5K171704CAPRI Corpectomy Cage SystemK2m201710—
+5K170851Anterior Spine Truss System (STS) Interbody Fusion Device4Web, Inc.20175—
+5K170919The TiBow Expandable Spacer SystemLife Spine, Inc.20171—
+5K171425Concorde LiftMedos International SARL201782
+5K170503EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular…Eit Emerging Implant Technologies GmbH20171992
+5K171046SeaSpine Cambria SystemSeaSpine Orthopedics Corporation201762—
+5K170844Gemini-C Hybrid Cervical Interbody SystemOsseus Fusion Systems, LLC20170—
+5K170961NuVasive CoRoent Small Interlock II SystemNu Vasive, Incorporated201718—
+5K170395Talos® Lumbar (HA) PEEK IBF DevicesMeditech Spine, LLC201710—
+5K162212Divergence-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc.201757—
+5K171097MOJAVE Expandable Interbody SystemK2m, Inc.201717—
+5K162496Foundation 3D InterbodyCorelink, LLC201782—
+5K170592NuVasive BASE Interfixated Titanium SystemNu Vasive, Incorporated2017186—
+5K163581Navigated ELEVATE Inserter, Navigated Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.2017103—
+5K162206Zavation IBFZavation, LLC201724—
+5K170455MectaLIF Anterior Stand AloneMedacta International S.A.20174—
+5K162760Spine Wave Anterior Cervical Spine SystemSpine Wave, Inc.20171—
+5K162680SOVEREIGN® Spinal SystemMedtronic Sofamor Danek USA, Inc.201631—
+5K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation201679—
+5K162103Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine…Choicespine, LP2016161—
+5K161993Leva® Anterior Interbody SystemSpine Wave, Inc.20160—
+5K162944Irix-C Cervical Integrated Fusion SystemX-Spine Systems, Inc.20161—
+5K153665Prow Fusion-LNlt Spine, Ltd.20160—
+5K160958Battalion Universal Spacer SystemAlphatec Spine2016114—
+5K160597INDEPENDENCE MIS SpacersGlobus Medical, Inc.2016111—
+5K161230NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated2016381—
+5K160906Rampart O Lumbar Interbody Fusion Device, Rampart T Lumbar Interbody Fusion Device…Spineology, Inc.201627—
+5K152622Alta ACDF SystemBiomet Spine20160—
+5K152011Lucent Intervertebral Body Fusion DeviceSpinal Elements, Inc.2016106—
+5K153436LATERAL Spine Truss System4Web, Inc.20165—
+5K153107Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine VEO™…Choicespine, LP2016171—
+5K160051NuVasive® Interfixated Interbody SystemNu Vasive, Incorporated2016396—
+5K153419NuVasive CoRoent Thoracolumbar SystemNu Vasive, Incorporated2016400—
+5K153495Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T…Ldr Spine USA20161891
+5K153400ProLift Expandable SystemLife Spine, Inc.201672—
+5K152539SpineView X-Pac Expandable Lumbar Cage SystemSpine View, Inc.20166—
+5K151726AVS AL and AVS ALign PEEK Spacers, AVS PL and AVS UniLIF PEEK Spacers, AVS TL PEEK…Stryker Corporation20161391
+5K151481Sahara Stabilization SystemK2m, Inc.20155—
+5K153122Endoskeleton (r) TCS SystemTitan Spine, LLC20151061
+5K151934ROI-C Titanium-Coated Implant SystemLdr Spine USA20159—
+5K152304Tritanium PL CageStryker20154481
+5K152259InFill Interbody Fusion DevicePinnacle Spine Group, LLC20152—
+5K152277PIVOX (tm) Oblique Lateral Spinal SystemMedtronic Sofamor Danek USA, Inc.2015190—
+5K151596Endoskeleton TCS Interbody Fusion DeviceTitan Spine, LLC20151101
+5K143479Bluefin Interbody SystemTides Medical20152—
+5K151756Sterispine LC CageSafe Orthopaedics20150—
+5K151374NuVasive MLX-Medial Lateral Expandable Lumbar Interbody System, NuVasive AP Expandable…Nu Vasive, Incorporated2015235—
+5K151483Biomet Spine Fusion SystemBiomet Spine, LLC20154—
+5K142645Avenue T TLIF CageLdr Spine USA, Inc.2015191—
+5K142269Reliance Cervical IBF SystemReliance Medical Systems, LLC201523—
+5K150130Ascendant TM Cervical Spacer SystemExactech, Inc.20157—
+5K142392Zavation Posterior LEIFZavation, LLC20150—
+5K143616AccuLIF TL and PL CageStryker Corporation20154694
+5K143228Ancora LLC Interbody Fusion DeviceFrontier Medical Devices, Inc.20150—
+5K142271Zavation Z-Link LumbarZavation, LLC20149—
+5K142023Luna Interbody SystemBenvenue Medical, Inc.20145—
+5K142066Aero-LL Lumbar Cage SystemStryker Corporation20142—
+5K142101Abacus (TM) Spacer SystemSpine Wave, Inc.20140—
+5K141005Z-Link CervicalZavation, LLC20144—
+5K133813Flxfit Intervertebral Body Fusion DeviceExpanding Orthopedics, Inc.2014137—
+5K123607Octane Elevate Spinal Implant SystemExactech, Inc.20141—
+5K133893Sterispine LC CageSafe Orthopaedics20141—
+5K133583Opticage Interbody Fusion Device, Model Series 9070Interventional Spine, Inc.20140—
+5K132559Monument SpacersGlobus Medical, Inc.2013166—
+5K131071Staxx Ibl SystemSpine Wave, Inc.20138—
+5K130194Acculif XL CageCoalign Innovations, Inc.20131—
+5K123281Acculif TL-Peek CageCoalign Innovations, Inc.2013146—
+5K123752Acculif TL and PL CageCoalign Innovations, Inc.2013676—
+5K121683Acculif TL CageCoalign Innovations, Inc.2012682—
+6K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+6K262489BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20260—
+6K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—
+6K261810Vertiwedge® Intraosseous SystemFoundation Surgical Group20260—
+6K261430TruLift Expandable SystemLife Spine, Inc.20260—
+6K2530413d Cage CervicalFims Co., Ltd.20260—
+6K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+6K262094E3D™-C Interbody SystemEvolution Spine20260—
+6K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+6K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+6K261279DeltaNEC Interbody SystemNexus Spine20260—
+6K253151Fule Interbody Fusion Cage SystemBeijing Fule Science & Technology Development Co., Ltd.20260—
+6K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+6K260810Anteralign LS coverplateTyber Medical, LLC20260—
+6K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, Inc.20260—
+6K261067BEE PLIF CageNGMedical GmbH20260—
+6K260660SABER-C SystemElevation Spine20261—
+6K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC20260—
+6K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine20260—
+6K252432Flex-Z™ Cervical CageSpinepoint, LLC20260—
+6K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+6K253545Vulcan Spinal SystemK2m, Inc.20260—
+6K260038E3D™-C Interbody SystemEvolution Spine20261—
+6K253748Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer SystemLife Spine, Inc.20260—
+6K254061Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc.20260—
+6K252711Advantage-C™ Ti3D Cervical Interbody Fusion DeviceIntelivation Technologies20260—
+6K252686EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC20251—
+6K253377Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc.20250—