510(k) Report

Devices descending from P950019

1,482 later devices reach Ray Threaded Fusion Cage (TFC)(TM) with Instrumentation through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K153615NeoFuse HA Enhanced PLIF/TLIFHt Medical, LLC201650—
+3K153720ENZA Zero-Profile Anterior Interbody FusionCamber Spine Technologies20164—
+3K153222Leva Spacer SystemSpine Wave, Inc.20165—
+3K151665SUSTAIN Additional ImplantsGlobus Medical, Inc.2016119—
+3K153438PERIMETER C (Titanium) Spinal SystemMedtronic Sofamor Danek USA, Inc.20160—
+3K151406Cogent Lateral Interbody SystemCogent Spine, LLC201611—
+3K152475FORZA PTC Spacer SystemOrthofix, Inc.2016236—
+3K153356Spine Innovation Interbody SystemSpine Innovation, LLC20161—
+3K151310Amendia Interbody Fusion DevicesAmendia, Inc.2016169—
+3K152515TOMCAT Cervical Spinal SystemChoicespine, LP2015108—
+3K153122Endoskeleton (r) TCS SystemTitan Spine, LLC20151061
+3K152355Twin Peaks Lumbar Interbody Fusion SystemSpineway20151—
+3K152943NuVasive Foundation-LL SystemNu Vasive, Incorporated2015187—
+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—
+3K151214ALIF Interfixated SystemNu Vasive, Incorporated2015220—
+3K150231Navigated Disc Prep Instruments and CAPSTONE TrialsMedtronic Sofamor Danek USA, Inc.2015242—
+3K150135DIVERGENCE-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc.2015228—
+3K142645Avenue T TLIF CageLdr Spine USA, Inc.2015191—
+3K142269Reliance Cervical IBF SystemReliance Medical Systems, LLC201523—
+3K150643Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-TiCentinel Spine, Inc.2015368—
+3K150130Ascendant TM Cervical Spacer SystemExactech, Inc.20157—
+3K150954Elite L Expandable Lumbar Fusion SystemInnova Spinal Technologies, LLC20156—
+3K143258PLIF STS, TLIF STS, OLIF STS (Spinal Truss System)4Web, Inc.2015211—
+3K141665NuVasive CoRoent SystemNuvasive, Inc.2015588—
+3K143163AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK Spacer…Stryker Corporation2015636—
+3K141187Impix Alif S/aMedicrea International SA201501
+3K133827A-Link ZOsteo Vasive, LLC2014262
+3K142066Aero-LL Lumbar Cage SystemStryker Corporation20142—
+3K141942Midline II TICentinel Spine, Inc.2014459—
+3K142101Abacus (TM) Spacer SystemSpine Wave, Inc.20140—
+3K142193Cogent Med-Lif XLCogent Spine, LLC201412—
+3K142277Juliet POSpineart2014119—
+3K141405Mobis II ST Spinal ImplantSignus Medizintechnik GmbH2014461—
+3K141443Infront Lumbar Interbody Fusion SystemInfront Medical, LLC20142—
+3K133947Irix-a Lumbar Integrated Fusion SystemX-Spine Systems, Inc.20142—
+3K140864Veloxtm Interbody Fusion SystemU&I Corp.20149—
+3K141376Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx, Struxxure Anterior…Nexxt Spine, LLC2014106—
+3K140709Skyhawk Interbody Fusion SystemOrthofix, Inc.20147—
+3K140303Alamo TAlliance Partners, LLC20140—
+3K140474Juliet OLSpineart2014120—
+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—
+3K140106S128 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, Inc.2014265—
+3K133529Camber Spine Coveris Cervical CageCamber Spine201410—
+3K132926Velofixtm Interbody Fusion SystemU&I Corp.201410—
+3K133557Juliet LL Lateral Lumbar CageSpineart2014147—
+3K133192Mectalif TipeekMedacta International201416—
+3K132894Optio-C Anterior Cervical SystemZimmer Spine, Inc.201424—
+3K133286Midline (TM)Centinel Spine, Inc.2014460—
+3K131276Lateral SynfixSynthes (USA) Products, LLC2014146—
+3K132601Coroent Sterile Implants SystemNu Vasive, Incorporated2013596—
+3K131669Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek USA, Inc.2013234—
+3K131178Idys Lif CagesClariance201311—
+3K130641Logic Stand-Alone Intervertebral Body Fusion DeviceBinder Biomedical, Inc.20130—
+3K130461Stalif XCentinel Spine, Inc.201313—
+3K123027Capstone (R) Spinal SystemMedtronic Sofamor Danek, Inc.2013709—
+3K131077Life Spine Plateau Spacer SystemLife Spine201310—
+3K122588Vusion CS PlusOrtho Development Corp.2013206—
+3K122639Synthes Syncage Evolution SpacerSynthes (USA) Products, LLC2013143—
+3K124034Mectalif AnteriorMedacta International201311—
+3K130506Imse P-TlifInstitute of Musculoskeletal Science & Education20130—
+3K123045Brigade Standalone SystemNuvasive, Inc.2013696—
+3K121254Camber Spine Technologies TLS 5.0 Inerbody CageCamber Spine Technologies201340—
+3K112700Frontier Sadl Interbody Fusion DeviceFrontier Medical Devices, Inc.20121—
+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—
+3K122444Cervical CageEisertech, LLC201222—
+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—
+3K120203TM-400 DeviceZimmer Trabecular Metal Technology, Inc.201220—
+3K113796Solitaire-C Cervical Spacer SystemEbi, LLC20121421
+3K120063Venus Lumbar Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd.201237—
+3K120557Solitarie Peek Anterior Spinal System-to BE Called Colitaire 35Biomet Spine & Bone Healing Technologies20121—
+3K120031Chesapeake Spinal SystemK2m, Inc.2012334—
+3K112561Nuvasive Coroent NO-Profile SystemNuvasive, Inc.201212—
+3K112862Mecta-CMedacta International201114—
+3K112405Clydesdales Spinal SystemMedtronic Sofamor Danek USA, Inc.2011296—
+3K110442Nanovis Intervertebral Body Fusion SystemNanovis, LLC201110—
+3K110783Venus Interbody Fixation System- Venus Plif/Tlif, Alif Peek CageL&K BIOMED Co., Ltd.201138—
+3K110063Sovereign Spinal SystemMedtronic Sofamor Danek, Inc.2011718—
+3K103369Vault Alif SystemSpinal USA201110—
+3K101301Stalif MidlineCentinel Spine2010474—
+3K101051Avs a-Lat Peek Spacers, Models 48750XXX, 48751XXX, 48752XXX, 48753XXXStryker Spine2010641—
+3K100802Aesculap Implant Systems Sibd Spinal SystemAesculap Implant Systems, Inc.2010461—
+3K100043Coroent XLR Standalone SystemNuvasive, Inc.2010744—
+3K093808Incite Innovation Stand Alone Interbody Fusion DeviceIncite Innovation, LLC2010113—
+3K093864Avs Align Peek Spacers Model 48328XXX, 48326XXXStryker Corp.2010637—
+3K093629Solitaire and Solitaire Peek Anterior Spinal SystemBiomet Spine20101431
+3K092211Chesapeake Spinal SystemK2m, Inc.2010450—