510(k) Report

Devices descending from K033517

1,528 later devices reach Spinal Concepts Inc. Cadence and Traxis through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K141333Arena-C Tifuse Cervical Intervertebral Body Fusion DeviceSpinefrontier, Inc.20140—
+6K141896Coroent SystemNu Vasive, Incorporated2014480—
+6K142347Amedica Valeo II Interbody Fusion DeviceAmedica Corp.20145—
+6K142066Aero-LL Lumbar Cage SystemStryker Corporation20142—
+6K141942Midline II TICentinel Spine, Inc.2014459—
+6K142150Ais Modulift VBR SystemAesculap Implant System, Inc.201447—
+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—
+6K142095Renovis S134 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, Inc.2014254—
+6K133577Clydesdale (R) Spinal SystemMedtronic Sofamor Danek USA, Inc.2014256—
+6K1421124WEB Spinal Implant Products4Web, Inc.201433—
+6K141005Z-Link CervicalZavation, LLC20144—
+6K140479Coroent XL-F SystemNu Vasive, Incorporated2014465—
+6K140529Everest Spinal SystemK2m, LLC201431—
+6K133802Ais Modulift VBR SystemAesculap Implant System, Inc.201448—
+6K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+6K134038Camber Spine Diagon Oblique CageCamber Spine201428—
+6K133967Interbody Cage SystemAurora Spine2014227—
+6K131276Lateral SynfixSynthes (USA) Products, LLC2014146—
+6K132757Everest Spinal SystemK2m, Inc.201341—
+6K131669Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek USA, Inc.2013234—
+6K132361Everest Spinal SystemK2m, Inc.201334—
+6K130434Octane Straight, Octane Straight - Lordotic, Octane Straight I/R, Octane Straight I/R -…Exactech, Inc.201311—
+6K130445Vault Alif SystemSpinal USA20139—
+6K122872Intervertebral Body Fusion DeviceDio Medical Co., Ltd.201316—
+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—
+7K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—
+7K261430TruLift Expandable SystemLife Spine, Inc.20260—
+7K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—
+7K2530413d Cage CervicalFims Co., Ltd.20260—
+7K262094E3D™-C Interbody SystemEvolution Spine20260—
+7K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+7K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+7K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, 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—
+7K253894BMD Titanium Spinal Fusion SystemGlobal Biomedica s.r.o.20260—
+7K260837VersaLift Expandable SystemLife Spine, Inc.20260—
+7K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+7K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+7K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC20260—
+7K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine20260—
+7K252432Flex-Z™ Cervical CageSpinepoint, LLC20260—
+7K253604TiLink-L Navigation InstrumentsSurGenTec, LLC20260—
+7K253583LUX Expandable Lumbar Interbody SystemXenix Medical20260—
+7K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+7K253545Vulcan Spinal SystemK2m, Inc.20260—
+7K260038E3D™-C Interbody SystemEvolution Spine20261—
+7K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+7K252711Advantage-C™ Ti3D Cervical Interbody Fusion DeviceIntelivation Technologies20260—
+7K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+7K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+7K250560BEE HANGMedical GmbH20250—
+7K252686EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC20251—
+7K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+7K253377Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc.20250—
+7K252322SIros-X SystemGenesys Spine20250—
+7K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+7K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+7K251479Mobarn 80:20 Lumbar Interbody Fusion System (Posterior Lumbar Interbody Fusion Cage…Mobarn Medical Devices, LLC20250—
+7K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+7K250247panaSIa SI Fusion SystemWenzel Spine, Inc.20250—
+7K241525ExcelsiusXR™Globus Medical, Inc.20250—
+7K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+7K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+7K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+7K250987aprevo® posterior/transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20251—
+7K251395The Rialto™ SI Fusion SystemMedtronic Sofamor Danek USA, Inc.20251—
+7K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+7K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+7K251459OneLIF™ Interbody Fusion SystemNovapproach Spine, LLC20250—
+7K251335Tera Lumbar Interbody Fusion System (Various PNs)Acuity Surgical Devices, LLC20251—
+7K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—
+7K242928Tesera-k SC SystemKyocera Medical Technologies, Inc.20250—
+7K243074Spectrum Spine Lumbar Cage SystemSpectrum Spine, Inc.20252—
+7K243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsSeaSpine Orthopedics Corporation20250—
+7K250186GoLIF! Lumbar Interbody Fusion SystemGetset Surgical, SA20250—
+7K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+7K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+7K243915FIX-C 3D Ti ACIF SystemJeil Medical Corporation20250—
+7K242483Genesys Spine AIS-C II Cervical Interbody Fusion SystemGenesys Spine20250—
+7K243739AxCess® Expandable Interbody SystemElliquence, LLC20250—
+7K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+7K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+7K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+7K242589Scarlet® AL-TSpineart SA20240—