510(k) Report

Devices descending from K042930

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K171567IRIX-A Lumbar Integrated Fusion SystemX-Spine Systems, Inc.201701
+6K170851Anterior Spine Truss System (STS) Interbody Fusion Device4Web, Inc.20175—
+6K171630LumFuse-TPPrecifit Medical, Ltd.20171—
+6K171749Velofix (tm) Interbody Fusion SystemU&I Corporation20175—
+6K170844Gemini-C Hybrid Cervical Interbody SystemOsseus Fusion Systems, LLC20170—
+6K163506Coalesce™ (-Straight, -Convex, -Crescent, -Lateral, -Anterior, or -Oblique) Lumbar…Vertera, Inc.2017224—
+6K162212Divergence-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc.201757—
+6K162918Atlas Spine Expandable Interbody SystemAtlas Spine, Inc.201729—
+6K161127The Small PLATEAU (PLATEAU-C) Spacer SystemLife Spine, Inc.20166—
+6K162680SOVEREIGN® Spinal SystemMedtronic Sofamor Danek USA, Inc.201631—
+6K162327COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL2016111—
+6K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc.20165—
+6K162431Luna 3D Interbody Fusion SystemBenvenue Medical, Inc.20163—
+6K160074Rampart D Lumbar Interbody Fusion DeviceSpineology, Inc.20165—
+6K161379ELSA SpacersGlobus Medical, Inc.2016155—
+6K161173Avenue® T TLIF CageLdr Spine USA, Inc.20163—
+6K160066Pro-Link® Stand-Alone Cervical Spacer SystemLife Spine, Inc.20163—
+6K160597INDEPENDENCE MIS SpacersGlobus Medical, Inc.2016111—
+6K161405Valeo II Interbody Fusion Device SystemAmedica Corp.20164—
+6K161210RIALTO (TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC (TM)…Medtronic Sofamor Danek201679—
+6K152099Genesys Spine Apache® Anchored Cervical Interbody Fusion SystemGenesys Spine201619—
+6K160605MectaLIF Anterior Stand-AloneMedacta International201610—
+6K161223TransContinental® M Spacers and InterContinental® Plate-SpacersGlobus Medical, Inc.2016117—
+6K153786Prow Fusion-VNlt Spine, Ltd.20166—
+6K153105MLX™ - Medial Lateral Expandable Lumbar Interbody SystemNu Vasive, Incorporated2016234—
+6K152501Spinal Jaxx Interbody Fusion DeviceNeuropro Spinaljaxx, Inc.201601
+6K160154ALTA Anterior Cervical Interbody SpacerAstura Medical201663—
+6K160051NuVasive® Interfixated Interbody SystemNu Vasive, Incorporated2016396—
+6K153495Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T…Ldr Spine USA20161891
+6K153782NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated2016390—
+6K153627NuVasive® TLX Interbody SystemNu Vasive, Incorporated2016252—
+6K151406Cogent Lateral Interbody SystemCogent Spine, LLC201611—
+6K160291Optimus ALIF SystemAmendia, Inc.20160—
+6K153442CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with…Medtronic Sofamor Danek USA, Inc.201684—
+6K152972Amendia Stand-Alone Cervical SystemAmendia, Inc.201632
+6K151310Amendia Interbody Fusion DevicesAmendia, Inc.2016169—
+6K152355Twin Peaks Lumbar Interbody Fusion SystemSpineway20151—
+6K151773CONCORDE Bullet Lumbar Interbody SystemMedos International SARL2015201—
+6K152259InFill Interbody Fusion DevicePinnacle Spine Group, LLC20152—
+6K152277PIVOX (tm) Oblique Lateral Spinal SystemMedtronic Sofamor Danek USA, Inc.2015190—
+6K151472NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated2015479—
+6K151322Amendia Interbody Fusion DevicesAmendia, Inc.20152261
+6K150673SYNFIX Evolution Secured Spacer SystemSynthes (USA) Products, LLC2015137—
+6K151140LnK Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.201529—
+6K151677LnK Cervical Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20158—
+6K150994NuVasive CoRoent Thoracolumbar ImplantsNu Vasive, Incorporated2015402—
+6K143595NuVasive (R) CCX-L Interbody SystemNu Vasive, Incorporated2015253—
+6K143616AccuLIF TL and PL CageStryker Corporation20154694
+6K143228Ancora LLC Interbody Fusion DeviceFrontier Medical Devices, Inc.20150—
+6K143163AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK Spacer…Stryker Corporation2015636—
+6K141135Juliet LLSpineart2014146—
+6K141896Coroent SystemNu Vasive, Incorporated2014480—
+6K142347Amedica Valeo II Interbody Fusion DeviceAmedica Corp.20145—
+6K142066Aero-LL Lumbar Cage SystemStryker Corporation20142—
+6K141942Midline II TICentinel Spine, Inc.2014459—
+6K141953Endoskeleton; TA Ibd and VBR, to and TT, Tas, TC, TLTitan Spine, LLC20142652
+6K142589Endoskeleton TA IBD and VBR, Endoskeleton TO and TT, Endoskeleton TAS, Endoskeleton TAS…Titan Spine, LLC2014106—
+6K142193Cogent Med-Lif XLCogent Spine, LLC201412—
+6K133577Clydesdale (R) Spinal SystemMedtronic Sofamor Danek USA, Inc.2014256—
+6K1421124WEB Spinal Implant Products4Web, Inc.201433—
+6K140479Coroent XL-F SystemNu Vasive, Incorporated2014465—
+6K140529Everest Spinal SystemK2m, LLC201431—
+6K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+6K131276Lateral SynfixSynthes (USA) Products, LLC2014146—
+6K132757Everest Spinal SystemK2m, Inc.201341—
+6K131669Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek USA, Inc.2013234—
+6K132361Everest Spinal SystemK2m, Inc.201334—
+6K131077Life Spine Plateau Spacer SystemLife Spine201310—
+6K130445Vault Alif SystemSpinal USA20139—
+6K123281Acculif TL-Peek CageCoalign Innovations, Inc.2013146—
+6K123752Acculif TL and PL CageCoalign Innovations, Inc.2013676—
+6K121649Construx Mini Peek TI Spacer SystemOrthofix2012289—
+6K112444Anatomic Peek Cervical Fusion SystemMedtronic Sofamor Danck USA, Inc.2011324—
+6K111264Cornerstone (R) PSR Cervical Fusion SystemMedtronic Sofamor Danek USA2011331—
+6K111166A-Wedge Anterior Interbody System (a-Wedge a.I.S.)Spineworks, LLC201123—
+6K111122Aesculap Sibd XP Spinal SystemAesculap Implant Systems, Inc.2011460—
+6K111675VU C*Pod Intervertebral Body Fusion DeviceTheken Spine, LLC201162—
+6K111835Plateau Spacer SystemLife Spine, Inc.2011120—
+6K102547Coroent Interlock SystemNuvasive, Inc.2011131—
+6K101310VU Apod Intervertebral Body Fusion DeviceTheken Spine, LLC2010480—
+7K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+7K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.20260—
+7K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—
+7K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+7K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+7K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+7K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+7K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+7K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+7K253604TiLink-L Navigation InstrumentsSurGenTec, LLC20260—
+7K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+7K252686EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC20251—
+7K253377Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc.20250—
+7K252322SIros-X SystemGenesys Spine20250—
+7K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+7K251444Endoskeleton™ Interbody SystemsMedtronic Sofamor Danek USA, Inc.20250—
+7K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—
+7K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+7K250247panaSIa SI Fusion SystemWenzel Spine, Inc.20250—
+7K241525ExcelsiusXR™Globus Medical, Inc.20250—