510(k) Report

Devices descending from K040928

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K171657ShurFit 2C Lumbar Interbody Fusion SystemPrecision Spine, Inc.20174—
+6K170503EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular…Eit Emerging Implant Technologies GmbH20171992
+6K171031CRESCENT™ Spinal SystemMedtronic Sofamor Danek2017144—
+6K171468FUSE Spinal SystemMedtronic Sofamor Danek20170—
+6K163673Fortilink™-C with TETRAfuse™ 3D TechnologyRti Surgical, Inc.201711—
+6K163670Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20173—
+6K163481HALF DOME Posterior Lumbar Interbody SystemAstura Medical201731—
+6K170592NuVasive BASE Interfixated Titanium SystemNu Vasive, Incorporated2017186—
+6K163269Endoskeleton (R) TAS Interbody Fusion Device / Endoskeleton (R) TAS Hyperlordotic…Titan Spine, LLC2017143—
+6K162206Zavation IBFZavation, LLC201724—
+6K162693VertebraLINK Fusion PlatformFacetlink Dba Linkspine20170—
+6K170512Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC20176—
+6K163543Biomet Fusion SystemZimmer Biomet Spine, Inc.2017124—
+6K162446FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK…Orthofix, Inc.20166—
+6K160222OIC Cervical PEEK SpacerThe Orthopaedic Implant Company20160—
+6K160074Rampart D Lumbar Interbody Fusion DeviceSpineology, Inc.20165—
+6K161379ELSA SpacersGlobus Medical, Inc.2016155—
+6K161129Pillar SA PTCOrthofix, Inc.201619—
+6K160699VIRTU Lumbar Spacer SystemMet 1 Technologies, LLC20162—
+6K161404Genesys Spine Apache® Lateral Lumbar Interbody Fusion SystemGenesys Spine201610—
+6K160631Keos Lumbar IBFDKeos20161—
+6K153517AnyPlus® Cervical PEEK Cage SystemGS Medical Co., Ltd.201612—
+6K153436LATERAL Spine Truss System4Web, Inc.20165—
+6K153629ArcadiusXP C Spinal SystemAesculap Implant Systems, Inc.20167—
+6K153615NeoFuse HA Enhanced PLIF/TLIFHt Medical, LLC201650—
+6K153783SpaceVision® PLIF, SpaceVision® OLIF, SpaceVision® TLIFSpinevision S.A.201613—
+6K152200SurgTech Interbody SystemSurgtech, Inc.20160—
+6K151665SUSTAIN Additional ImplantsGlobus Medical, Inc.2016119—
+6K160418PERIMETER Interbody Fusion DeviceMedtronic Sofamor Danek USA, Inc.20165—
+6K152620Spine Wave Gen II Expandable Interbody SystemSpine Wave, Inc.20162—
+6K152475FORZA PTC Spacer SystemOrthofix, Inc.2016236—
+6K153356Spine Innovation Interbody SystemSpine Innovation, LLC20161—
+6K153122Endoskeleton (r) TCS SystemTitan Spine, LLC20151061
+6K152943NuVasive Foundation-LL SystemNu Vasive, Incorporated2015187—
+6K151785Px HA PEEK IBF SystemInnovasis, Inc.201557—
+6K151596Endoskeleton TCS Interbody Fusion DeviceTitan Spine, LLC20151101
+6K151756Sterispine LC CageSafe Orthopaedics20150—
+6K150847Foundation Interbody DevicesCorelink, LLC201529—
+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—
+6K151184InFill Interbody Fusion DevicesPinnacle Spine Group, LLC20153—
+6K151214ALIF Interfixated SystemNu Vasive, Incorporated2015220—
+6K150231Navigated Disc Prep Instruments and CAPSTONE TrialsMedtronic Sofamor Danek USA, Inc.2015242—
+6K142645Avenue T TLIF CageLdr Spine USA, Inc.2015191—
+6K150643Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-TiCentinel Spine, Inc.2015368—
+6K150130Ascendant TM Cervical Spacer SystemExactech, Inc.20157—
+6K150954Elite L Expandable Lumbar Fusion SystemInnova Spinal Technologies, LLC20156—
+6K142744Mecta-C TiPEEKMedacta International201512—
+6K142392Zavation Posterior LEIFZavation, LLC20150—
+6K140348Interbody CageEisertech, LLC2015235—
+6K143360LnK Cervical Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20159—
+6K150206InFill Interbody Fusion DevicesPinnacle Spine Group, LLC20152—
+6K141665NuVasive CoRoent SystemNuvasive, Inc.2015588—
+6K141187Impix Alif S/aMedicrea International SA201501
+6K142271Zavation Z-Link LumbarZavation, LLC20149—
+6K142277Juliet POSpineart2014119—
+6K141005Z-Link CervicalZavation, LLC20144—
+6K133947Irix-a Lumbar Integrated Fusion SystemX-Spine Systems, Inc.20142—
+6K140709Skyhawk Interbody Fusion SystemOrthofix, Inc.20147—
+6K140303Alamo TAlliance Partners, LLC20140—
+6K140474Juliet OLSpineart2014120—
+6K132738Cogent Med-LifCogent Spine, LLC201413—
+6K132596Proposed OptimusCustom Spine, Inc.201451
+6K134038Camber Spine Diagon Oblique CageCamber Spine201428—
+6K133893Sterispine LC CageSafe Orthopaedics20141—
+6K133192Mectalif TipeekMedacta International201416—
+6K123758Tasmin RSignus Medizintechnik GmbH20141—
+6K133286Midline (TM)Centinel Spine, Inc.2014460—
+6K133216Crescent Spinal SystemMedtronic Sofamor Danek, Inc.201392—
+6K132700Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek, Inc.2013170—
+6K130461Stalif XCentinel Spine, Inc.201313—
+6K123027Capstone (R) Spinal SystemMedtronic Sofamor Danek, Inc.2013709—
+6K122957Tezo Titanium Cage FamilyUlrich GmbH & Co. KG20130—
+6K124034Mectalif AnteriorMedacta International201311—
+6K123045Brigade Standalone SystemNuvasive, Inc.2013696—
+6K123997TRANS1LATERAL Interbody Fusion SystemTrans1, Inc.2013173—
+6K112700Frontier Sadl Interbody Fusion DeviceFrontier Medical Devices, Inc.20121—
+6K120869Anchor-L Lumbar CageStryker Spine2012638—
+6K1217414-Web Cervical STS (Spinal Truss System)4-Web, Inc.201235—
+6K122085Stingray Cervical CageOmni Surgical, LP Dba Spine36020120—
+6K121567Oracle Lumbar Intervertebral Body Fusion Cage SystemAccel Spine20125—
+6K122591Clydesdale Spinal SystemMedtronic Sofamor Danek, Inc.201214—
+6K121892Phantom Plus Ceramic Cage SystemAmedica Corp.20127—
+6K120991TRANS1 Interbody Fusion SystemTrans1 Incorporated2012172—
+6K121982Sovereign Spinal SystemMedtronic Sofamor Danek2012155—
+6K121096Venus Lumbar Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd.201236—
+6K121683Acculif TL CageCoalign Innovations, Inc.2012682—
+6K121116Plateau Spacer SystemLife Spine201213—
+6K120063Venus Lumbar Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd.201237—
+6K120656Everest Spinal SystemK2m, Inc.201243—
+6K112561Nuvasive Coroent NO-Profile SystemNuvasive, Inc.201212—
+6K120024Mectalif TransforaminalMedacta International S.A.201223—
+6K113642Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek USA2012292—
+6K112405Clydesdales Spinal SystemMedtronic Sofamor Danek USA, Inc.2011296—
+6K110063Sovereign Spinal SystemMedtronic Sofamor Danek, Inc.2011718—
+6K111626Endoskeleton (R) TasTitan Spine, LLC2011273—
+6K111525Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek2011355—
+6K103655Octane-C Interbody Fusion Device SystemExactech, Inc.2011481
+6K103369Vault Alif SystemSpinal USA201110—
+6K101363VU Cpod Intervertebral Bodu Fusion DeviceMusculoskeletal Clinical Regulatory Advisers201078—