510(k) Report

Devices descending from P970015

1,426 later devices reach Inter Fix Threaded Fusion Device through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K153720ENZA Zero-Profile Anterior Interbody FusionCamber Spine Technologies20164—
+3K160051NuVasive® Interfixated Interbody SystemNu Vasive, Incorporated2016396—
+3K153495Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T…Ldr Spine USA20161891
+3K152200SurgTech Interbody SystemSurgtech, Inc.20160—
+3K153782NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated2016390—
+3K151665SUSTAIN Additional ImplantsGlobus Medical, Inc.2016119—
+3K153438PERIMETER C (Titanium) Spinal SystemMedtronic Sofamor Danek USA, Inc.20160—
+3K153356Spine Innovation Interbody SystemSpine Innovation, LLC20161—
+3K152475FORZA PTC Spacer SystemOrthofix, Inc.2016236—
+3K151310Amendia Interbody Fusion DevicesAmendia, Inc.2016169—
+3K151481Sahara Stabilization SystemK2m, Inc.20155—
+3K152515TOMCAT Cervical Spinal SystemChoicespine, LP2015108—
+3K153122Endoskeleton (r) TCS SystemTitan Spine, LLC20151061
+3K152355Twin Peaks Lumbar Interbody Fusion SystemSpineway20151—
+3K150673SYNFIX Evolution Secured Spacer SystemSynthes (USA) Products, LLC2015137—
+3K151756Sterispine LC CageSafe Orthopaedics20150—
+3K150481Cascadia Interbody SystemK2m, Inc.20154593
+3K151128CAPSTONE Spinal System, CLYDESDALE Spinal SystemMedtronic Sofamor Danek USA, Inc.2015255—
+3K151184InFill Interbody Fusion DevicesPinnacle Spine Group, LLC20153—
+3K150500Px PEEK IBF SystemInnovasis, Inc.201558—
+3K150231Navigated Disc Prep Instruments and CAPSTONE TrialsMedtronic Sofamor Danek USA, Inc.2015242—
+3K142645Avenue T TLIF CageLdr Spine USA, Inc.2015191—
+3K142269Reliance Cervical IBF SystemReliance Medical Systems, LLC201523—
+3K150130Ascendant TM Cervical Spacer SystemExactech, Inc.20157—
+3K150521Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) SystemRti Surgical, Inc. Dba Rti Biologics201512—
+3K142487Chesapeake Stabilization SystemK2m, Inc.201571
+3K150954Elite L Expandable Lumbar Fusion SystemInnova Spinal Technologies, LLC20156—
+3K142456GPS SpacersG Surgical, LLC20151—
+3K141665NuVasive CoRoent SystemNuvasive, Inc.2015588—
+3K143163AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK Spacer…Stryker Corporation2015636—
+3K141135Juliet LLSpineart2014146—
+3K142066Aero-LL Lumbar Cage SystemStryker Corporation20142—
+3K141942Midline II TICentinel Spine, Inc.2014459—
+3K142101Abacus (TM) Spacer SystemSpine Wave, Inc.20140—
+3K142277Juliet POSpineart2014119—
+3K141405Mobis II ST Spinal ImplantSignus Medizintechnik GmbH2014461—
+3K140479Coroent XL-F SystemNu Vasive, Incorporated2014465—
+3K140864Veloxtm Interbody Fusion SystemU&I Corp.20149—
+3K140055Endoskeleton (R) TL Interbody Fusion DeviceTitan Spine, LLC2014267—
+3K133494Chesapeake Spinal SystemK2m, Inc.2014330—
+3K140564BN Lumbar Cage SystemMedyssey USA, Inc.20143—
+3K140303Alamo TAlliance Partners, LLC20140—
+3K140474Juliet OLSpineart2014120—
+3K132738Cogent Med-LifCogent Spine, LLC201413—
+3K132596Proposed OptimusCustom Spine, Inc.201451
+3K133340Spineworks Anterior Lumbar DeviceSpineworks, LLC201413—
+3K133614Aleutian Ibf SystemK2m, Inc.2014527—
+3K140003Coroent Small Interbody SystemNuvasive, Inc.2014453—
+3K133721Infill 41-Tlif Convex Oblique Device, Infill 43-Tlif Contour Oblique, Infill 44-Tlif…Pinnacle Spine Group, LLC20145—
+3K133455Crossfuse II Coronal Taper, Crossfuse II HyperlordoticPioneer Surgical Technology, Inc.20145961
+3K132926Velofixtm Interbody Fusion SystemU&I Corp.201410—
+3K133623C-PLUSPioneer Surgical Technology, Inc.2014598—
+3K133557Juliet LL Lateral Lumbar CageSpineart2014147—
+3K133192Mectalif TipeekMedacta International201416—
+3K123758Tasmin RSignus Medizintechnik GmbH20141—
+3K131276Lateral SynfixSynthes (USA) Products, LLC2014146—
+3K131669Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek USA, Inc.2013234—
+3K131178Idys Lif CagesClariance201311—
+3K131122S128 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, LLC2013269—
+3K130948C-Fuse Cervical Intervertebral Body Fusion SystemSouthern Spine, LLC201313—
+3K123027Capstone (R) Spinal SystemMedtronic Sofamor Danek, Inc.2013709—
+3K122588Vusion CS PlusOrtho Development Corp.2013206—
+3K130506Imse P-TlifInstitute of Musculoskeletal Science & Education20130—
+3K130445Vault Alif SystemSpinal USA20139—
+3K120464Innesis Peek CageBk Meditech, Co., Ltd.20136—
+3K121254Camber Spine Technologies TLS 5.0 Inerbody CageCamber Spine Technologies201340—
+3K112700Frontier Sadl Interbody Fusion DeviceFrontier Medical Devices, Inc.20121—
+3K122956Fuselox Lumbar Interbody Fusion DeviceCaptiva Spine20122—
+3K122989Biomet Lateral Spacer SystemBiomet Spine (Aka Ebi, LLC)2012171—
+3K122168Visualif Challenging Access PlateSpine Smith Partners L.P.20121—
+3K121567Oracle Lumbar Intervertebral Body Fusion Cage SystemAccel Spine20125—
+3K122591Clydesdale Spinal SystemMedtronic Sofamor Danek, Inc.201214—
+3K120991TRANS1 Interbody Fusion SystemTrans1 Incorporated2012172—
+3K121096Venus Lumbar Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd.201236—
+3K121683Acculif TL CageCoalign Innovations, Inc.2012682—
+3K121211VU Apod Intervertebral Body Fusion DeviceTheken Spine, LLC2012129—
+3K121246Medyssy LT Cage SystemMedyssey Co, Ltd.20122—
+3K120396Reliance Cervical Ibf SystemReliance Medical Systems, LLC201225—
+3K120063Venus Lumbar Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd.201237—
+3K112862Mecta-CMedacta International201114—
+3K112405Clydesdales Spinal SystemMedtronic Sofamor Danek USA, Inc.2011296—
+3K110442Nanovis Intervertebral Body Fusion SystemNanovis, LLC201110—
+3K110063Sovereign Spinal SystemMedtronic Sofamor Danek, Inc.2011718—
+3K112496Pioneer Crossfuse II Ibf/VBR SystemPioneer Surgical Technology, Inc.2011604—
+3K111166A-Wedge Anterior Interbody System (a-Wedge a.I.S.)Spineworks, LLC201123—
+3K111439Chesapeake (Cervical Components)K2m, Inc.20113451
+3K111122Aesculap Sibd XP Spinal SystemAesculap Implant Systems, Inc.2011460—
+3K103111Forza Spacer SystemOrthofix, Inc.20113431
+3K102547Coroent Interlock SystemNuvasive, Inc.2011131—
+3K100210TRANS1 Lateral Intervertebral Fusion Device, TTrans1 Incorporated2010175—
+3K092540C-PS Peek Optima Cervical Interbody Spacer, L-PS Peek Optima Lumbar Interbody SpacerRsb Spine, LLC201045—
+4K262726NeckTune™ SA Cervical CageMedyssey Co., Ltd.20260—
+4K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+4K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+4K261049Scala® TLSpineart SA20260—
+4K261810Vertiwedge® Intraosseous SystemFoundation Surgical Group20260—
+4K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+4K262094E3D™-C Interbody SystemEvolution Spine20260—
+4K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+4K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—