510(k) Report

Devices descending from K042930

1,440 later devices reach Spacevision Cage System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K172341NuVasive® Modulus TLIF Interbody SystemNu Vasive, Incorporated2017163—
+5K171914Cortina™ Lumbar Cage SystemNeurostructures, Inc.20172—
+5K172343Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D TechnologyRti Surgical, Inc.201710—
+5K172123NuVasive® Modulus XLIF Interbody SystemNu Vasive, Incorporated2017227—
+5K172199ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT…Medtronic Sofamor Danek20176—
+5K163422Shanghai Sanyou PEEK Cage SystemShanghai Sanyou Medical Co, Ltd.20173—
+5K172587Mecta-C with titanium markers and Mecta-C TiPEEK with titanium markersMedacta International S.A.20170—
+5K172064Ti-Diagon Oblique TLIFCamber Spine Technologies201727—
+5K171351Posterior Spine Truss System (PSTS) Interbody Fusion Device4Web, Inc.20177—
+5K172489Reliance Cervical IBF SystemReliance Medical Systems, LLC201716—
+5K171704CAPRI Corpectomy Cage SystemK2m201710—
+5K171657ShurFit 2C Lumbar Interbody Fusion SystemPrecision Spine, Inc.20174—
+5K170503EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular…Eit Emerging Implant Technologies GmbH20171992
+5K171031CRESCENT™ Spinal SystemMedtronic Sofamor Danek2017144—
+5K171468FUSE Spinal SystemMedtronic Sofamor Danek20170—
+5K163673Fortilink™-C with TETRAfuse™ 3D TechnologyRti Surgical, Inc.201711—
+5K163670Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20173—
+5K163481HALF DOME Posterior Lumbar Interbody SystemAstura Medical201731—
+5K170592NuVasive BASE Interfixated Titanium SystemNu Vasive, Incorporated2017186—
+5K163581Navigated ELEVATE Inserter, Navigated Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.2017103—
+5K163269Endoskeleton (R) TAS Interbody Fusion Device / Endoskeleton (R) TAS Hyperlordotic…Titan Spine, LLC2017143—
+5K162206Zavation IBFZavation, LLC201724—
+5K162693VertebraLINK Fusion PlatformFacetlink Dba Linkspine20170—
+5K170512Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC20176—
+5K1624024CIS® Marlin ACIF Cage SystemSolco Biomedical Co., Ltd.20171—
+5K162446FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK…Orthofix, Inc.20166—
+5K160222OIC Cervical PEEK SpacerThe Orthopaedic Implant Company20160—
+5K153665Prow Fusion-LNlt Spine, Ltd.20160—
+5K161129Pillar SA PTCOrthofix, Inc.201619—
+5K160699VIRTU Lumbar Spacer SystemMet 1 Technologies, LLC20162—
+5K161404Genesys Spine Apache® Lateral Lumbar Interbody Fusion SystemGenesys Spine201610—
+5K160631Keos Lumbar IBFDKeos20161—
+5K160874Nanovis Intervertebral Body Fusion System and FortiCore®Nanovis, LLC20164—
+5K153517AnyPlus® Cervical PEEK Cage SystemGS Medical Co., Ltd.201612—
+5K153436LATERAL Spine Truss System4Web, Inc.20165—
+5K153629ArcadiusXP C Spinal SystemAesculap Implant Systems, Inc.20167—
+5K153615NeoFuse HA Enhanced PLIF/TLIFHt Medical, LLC201650—
+5K153783SpaceVision® PLIF, SpaceVision® OLIF, SpaceVision® TLIFSpinevision S.A.201613—
+5K152200SurgTech Interbody SystemSurgtech, Inc.20160—
+5K151665SUSTAIN Additional ImplantsGlobus Medical, Inc.2016119—
+5K160418PERIMETER Interbody Fusion DeviceMedtronic Sofamor Danek USA, Inc.20165—
+5K153438PERIMETER C (Titanium) Spinal SystemMedtronic Sofamor Danek USA, Inc.20160—
+5K152475FORZA PTC Spacer SystemOrthofix, Inc.2016236—
+5K153356Spine Innovation Interbody SystemSpine Innovation, LLC20161—
+5K153122Endoskeleton (r) TCS SystemTitan Spine, LLC20151061
+5K152943NuVasive Foundation-LL SystemNu Vasive, Incorporated2015187—
+5K151785Px HA PEEK IBF SystemInnovasis, Inc.201557—
+5K151596Endoskeleton TCS Interbody Fusion DeviceTitan Spine, LLC20151101
+5K151408LOSPA IS Spinal SystemCorentec Co., Ltd.20151—
+5K151756Sterispine LC CageSafe Orthopaedics20150—
+5K150847Foundation Interbody DevicesCorelink, LLC201529—
+5K151128CAPSTONE Spinal System, CLYDESDALE Spinal SystemMedtronic Sofamor Danek USA, Inc.2015255—
+5K151374NuVasive MLX-Medial Lateral Expandable Lumbar Interbody System, NuVasive AP Expandable…Nu Vasive, Incorporated2015235—
+5K151184InFill Interbody Fusion DevicesPinnacle Spine Group, LLC20153—
+5K151214ALIF Interfixated SystemNu Vasive, Incorporated2015220—
+5K150231Navigated Disc Prep Instruments and CAPSTONE TrialsMedtronic Sofamor Danek USA, Inc.2015242—
+5K150135DIVERGENCE-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc.2015228—
+5K142645Avenue T TLIF CageLdr Spine USA, Inc.2015191—
+5K142269Reliance Cervical IBF SystemReliance Medical Systems, LLC201523—
+5K150643Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-TiCentinel Spine, Inc.2015368—
+5K150954Elite L Expandable Lumbar Fusion SystemInnova Spinal Technologies, LLC20156—
+5K142744Mecta-C TiPEEKMedacta International201512—
+5K142392Zavation Posterior LEIFZavation, LLC20150—
+5K140348Interbody CageEisertech, LLC2015235—
+5K143360LnK Cervical Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20159—
+5K150206InFill Interbody Fusion DevicesPinnacle Spine Group, LLC20152—
+5K141665NuVasive CoRoent SystemNuvasive, Inc.2015588—
+5K141187Impix Alif S/aMedicrea International SA201501
+5K142271Zavation Z-Link LumbarZavation, LLC20149—
+5K133827A-Link ZOsteo Vasive, LLC2014262
+5K142101Abacus (TM) Spacer SystemSpine Wave, Inc.20140—
+5K142095Renovis S134 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, Inc.2014254—
+5K142277Juliet POSpineart2014119—
+5K140280ForticoreNanovis, LLC20149—
+5K141005Z-Link CervicalZavation, LLC20144—
+5K133947Irix-a Lumbar Integrated Fusion SystemX-Spine Systems, Inc.20142—
+5K140864Veloxtm Interbody Fusion SystemU&I Corp.20149—
+5K140709Skyhawk Interbody Fusion SystemOrthofix, Inc.20147—
+5K140303Alamo TAlliance Partners, LLC20140—
+5K140474Juliet OLSpineart2014120—
+5K132738Cogent Med-LifCogent Spine, LLC201413—
+5K132596Proposed OptimusCustom Spine, Inc.201451
+5K132483Innesis Peek Cervical CageBk Meditech, Co., Ltd.20140—
+5K134038Camber Spine Diagon Oblique CageCamber Spine201428—
+5K133893Sterispine LC CageSafe Orthopaedics20141—
+5K132926Velofixtm Interbody Fusion SystemU&I Corp.201410—
+5K132582Exactech Acapella One Cervical Spacer SystemExactech, Inc.2014471
+5K133557Juliet LL Lateral Lumbar CageSpineart2014147—
+5K133192Mectalif TipeekMedacta International201416—
+5K123758Tasmin RSignus Medizintechnik GmbH20141—
+5K133286Midline (TM)Centinel Spine, Inc.2014460—
+5K133216Crescent Spinal SystemMedtronic Sofamor Danek, Inc.201392—
+5K132700Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek, Inc.2013170—
+5K131429Reliance Cervical Ibf SystemReliance Medical Systems, LLC201324—
+5K130641Logic Stand-Alone Intervertebral Body Fusion DeviceBinder Biomedical, Inc.20130—
+5K130461Stalif XCentinel Spine, Inc.201313—
+5K123027Capstone (R) Spinal SystemMedtronic Sofamor Danek, Inc.2013709—
+5K122957Tezo Titanium Cage FamilyUlrich GmbH & Co. KG20130—
+5K124034Mectalif AnteriorMedacta International201311—
+5K123045Brigade Standalone SystemNuvasive, Inc.2013696—