510(k) Report

Devices descending from K031635

1,201 later devices reach Depuy Acromed VBR System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K181261Curiteva Cervical Interbody Fusion SystemCuriteva, LLC20184—
+5K181203Juliet TiSpineart20181—
+5K180364HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC2018106—
+5K173832InTice™-C Porous Ti Cervical Interbody SystemX-Spine Systems, Inc.201801
+5K180071STYLO Interbody Fusion DeviceLegend Spine Technologies20180—
+5K173782UNiD Patient Specific 3D printed cageMedicrea International SA201823—
+5K173606SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu…SeaSpine Orthopedics Corporation201859—
+5K171495Zyston Strut Open Titanium Spacer SystemZimmer Biomet Spine, Inc.20181—
+5K173283Reliance Lumbar IBF SystemReliance Medical Systems, LLC20189—
+5K173702Juliet Ti LLSpineart20182—
+5K173102Reliance Cervical IBF SystemReliance Medical Systems, LLC201715—
+5K171434ROCCIA® MultiLIFSilony Medical GmbH20174—
+5K172926SeaSpine Vu cPOD, Zuma-C, Complete CervicalSeaSpine Orthopedics Corporation201761—
+5K173115COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and…Globus Medical, Inc.201783—
+5K172419Velofix™ TLIF CageU&I Corporation20172—
+5K173260SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica…SeaSpine Orthopedics Corporation201767—
+5K162315FORTIFY Corpectomy SpacersGlobus Medical, Inc.201755—
+5K172083Idys™ ALIF SystemClariance, Sas20177—
+5K172392Lateral Spinal Truss System (LSTS) Interbody Fusion Device4Web, Inc.20171—
+5K172437CONSTRUX® Mini PTC Spacer System, FORZA® PTC Spacer System, PILLAR® SA PTC Spacer SystemOrthofix, Inc.2017143
+5K173080IVA Cage Ti (ACIF, PLIF, TLIF, DLIF, and ALIF)Huvexel Co., Ltd.20172—
+5K171489Acapella Cervical Spacer SystemChoicespine, LP201739—
+5K163366Shanghai Sanyou CARMEN Cervical Fusion SystemShanghai Sanyou Medical Co, Ltd.20170—
+5K170157INDEPENDENCE® SpacersGlobus Medical, Inc.2017109—
+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—
+5K171567IRIX-A Lumbar Integrated Fusion SystemX-Spine Systems, Inc.201701
+5K170851Anterior Spine Truss System (STS) Interbody Fusion Device4Web, Inc.20175—
+5K163589SIGN IM NailSign Fracture Care International20170—
+5K170503EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular…Eit Emerging Implant Technologies GmbH20171992
+5K170844Gemini-C Hybrid Cervical Interbody SystemOsseus Fusion Systems, LLC20170—
+5K161710Sagico Ibf System – Aria Lumbar, Sagico Ibf System – Arion CervicalSpinal Analytics & Geometrical Impant Co, LLC201741—
+5K170962NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated2017304—
+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—
+5K163581Navigated ELEVATE Inserter, Navigated Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.2017103—
+5K162206Zavation IBFZavation, LLC201724—
+5K170455MectaLIF Anterior Stand AloneMedacta International S.A.20174—
+5K162918Atlas Spine Expandable Interbody SystemAtlas Spine, Inc.201729—
+5K162879Elite Expandable Interbody Fusion DeviceSpineology, Inc.20179—
+5K162680SOVEREIGN® Spinal SystemMedtronic Sofamor Danek USA, Inc.201631—
+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—
+5K160076XCage™ Interbody Fusion SystemOuroboros Medical, Inc.2016141
+5K160646XYcor® Expandable Spinal Spacer SystemAlphatec Spine, Inc.201641—
+5K160906Rampart O Lumbar Interbody Fusion Device, Rampart T Lumbar Interbody Fusion Device…Spineology, Inc.201627—
+5K152622Alta ACDF SystemBiomet Spine20160—
+5K152501Spinal Jaxx Interbody Fusion DeviceNeuropro Spinaljaxx, Inc.201601
+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—
+5K151665SUSTAIN Additional ImplantsGlobus Medical, Inc.2016119—
+5K152620Spine Wave Gen II Expandable Interbody SystemSpine Wave, Inc.20162—
+5K153356Spine Innovation Interbody SystemSpine Innovation, LLC20161—
+5K151312VerteLP Interbody Fusion DeviceVgi, LLC201601
+5K151481Sahara Stabilization SystemK2m, Inc.20155—
+5K153122Endoskeleton (r) TCS SystemTitan Spine, LLC20151061
+5K151934ROI-C Titanium-Coated Implant SystemLdr Spine USA20159—
+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
+5K151756Sterispine LC CageSafe Orthopaedics20150—
+5K151374NuVasive MLX-Medial Lateral Expandable Lumbar Interbody System, NuVasive AP Expandable…Nu Vasive, Incorporated2015235—
+5K142269Reliance Cervical IBF SystemReliance Medical Systems, LLC201523—
+5K150130Ascendant TM Cervical Spacer SystemExactech, Inc.20157—
+5K142392Zavation Posterior LEIFZavation, LLC20150—
+5K142218Coalition AGX Plate and Coalition AGX SpacerGlobus Medical, Inc.2015155—
+5K142634Biomet Spine Fusion SystemBiomet Spine, LLC20155—
+5K142498MAGNIFY and MAGNIFY-S SpacersGlobus Medical, Inc.2015175—
+5K142996StaXx (R) XD SystemSpine Wave, Inc.20150—
+5K143163AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK Spacer…Stryker Corporation2015636—
+5K142271Zavation Z-Link LumbarZavation, LLC20149—
+5K140716Opticage Expandable Interbody Fusion DeviceInterventional Spine, Inc.20140—
+5K142101Abacus (TM) Spacer SystemSpine Wave, Inc.20140—
+5K133717Longbow Spacer SystemLife Spine20149—
+5K141443Infront Lumbar Interbody Fusion SystemInfront Medical, LLC20142—
+5K141005Z-Link CervicalZavation, LLC20144—
+5K140479Coroent XL-F SystemNu Vasive, Incorporated2014465—
+5K140411Altera SpacerGlobus Medical, Inc.201419122
+5K133418Integra Expandable Interverebral Body Fusion Device (Ibd) SystemSeaspine, Inc.20145—
+5K133514Xcage Interbody Fusion SystemOuroboros Medical201415—
+5K133893Sterispine LC CageSafe Orthopaedics20141—
+5K131276Lateral SynfixSynthes (USA) Products, LLC2014146—
+5K131723Coroent Single Tab SystemNuvasive, Inc.2013466—
+5K130461Stalif XCentinel Spine, Inc.201313—
+5K124012Infill Oblique Tlif DevicePinnacle Spine Group, LLC20136—
+5K123461Staxx (R) IB SystemSpine Wave, Inc.2013251
+5K123231Caliber SpacersGlobus Medical, Inc.2013657—
+5K123180Falcon SpacerSynthes (USA) Products, LLC2013147—
+5K113285LDR Spine Usa Avenue L Interbody FusionLdr Spine USA, Inc.2012199—
+5K121733Infill Intervertebral Body Fusion DevicePinnacle Spine Group, LLC201221—
+5K120101Independence SpacerGlobus Medical, Inc.2012224—
+5K113447Rise SpacerGlobus Medical, Inc.2012691—
+5K113527Opticage Interbody Fusion DeviceInterventional Spine, Inc.2012103—
+5K113465Acculif TL CageCoalign Innovations, Inc.2011718—
+5K112095Acculif TL-Peek Ibf CageCoalign Innovations, Inc.2011319—
+6K262230Mg OSTEOREVIVE™;Mg OSTEOCRETE™Bone Solutions, Inc.20260—