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
+4K180078Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF SystemInnovasis, Inc.2018551
+4K180431Cortina [MAX] Lumbar Cage SystemNeurostructures, Inc.20181—
+4K173077Cavetto-SA Cervical Cage SystemNeurostructures, Inc.201821—
+4K172941CASCADIA Interbody SystemK2m201852—
+4K172816TiGer Shark™ SystemChoicespine, LP201859—
+4K173702Juliet Ti LLSpineart20182—
+4K173102Reliance Cervical IBF SystemReliance Medical Systems, LLC201715—
+4K171848FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO…Globus Medical, Inc.201755—
+4K173182ProLift® Expandable SystemLife Spine, Inc.201737—
+4K172465Idys™ TLIF 3DTi CagesClariance, Sas20176—
+4K172676NuVasive® Modulus-C Interbody SystemNu Vasive, Incorporated2017125—
+4K172009Cascadia Interbody SystemK2m, Inc.2017433
+4K172756Varian cageMedyssey USA, Inc.20171—
+4K173153Vertera Spine™ Coalesce™ Thoracolumbar Interbody Fusion SystemNu Vasive, Incorporated2017160—
+4K172019Brisbane ALIF Device, Gladstone ALIF DeviceSignature Orthopaedics Pty, Ltd.20170—
+4K172392Lateral Spinal Truss System (LSTS) Interbody Fusion Device4Web, Inc.20171—
+4K172437CONSTRUX® Mini PTC Spacer System, FORZA® PTC Spacer System, PILLAR® SA PTC Spacer SystemOrthofix, Inc.2017143
+4K172341NuVasive® Modulus TLIF Interbody SystemNu Vasive, Incorporated2017163—
+4K172343Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D TechnologyRti Surgical, Inc.201710—
+4K172123NuVasive® Modulus XLIF Interbody SystemNu Vasive, Incorporated2017227—
+4K171633NuVasive TLX Interbody SystemNu Vasive, Incorporated2017251—
+4K170157INDEPENDENCE® SpacersGlobus Medical, Inc.2017109—
+4K172587Mecta-C with titanium markers and Mecta-C TiPEEK with titanium markersMedacta International S.A.20170—
+4K172064Ti-Diagon Oblique TLIFCamber Spine Technologies201727—
+4K172489Reliance Cervical IBF SystemReliance Medical Systems, LLC201716—
+4K170888Renovis S141 Lumbar Interbody Fusion SystemRenovis Surgical Technologies20175—
+4K171630LumFuse-TPPrecifit Medical, Ltd.20171—
+4K171749Velofix (tm) Interbody Fusion SystemU&I Corporation20175—
+4K170318NeoFuse Ti3D PLIF/TLIF/Cervical InterbodyHt Medical, LLC201749—
+4K170503EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular…Eit Emerging Implant Technologies GmbH20171992
+4K170961NuVasive CoRoent Small Interlock II SystemNu Vasive, Incorporated201718—
+4K163673Fortilink™-C with TETRAfuse™ 3D TechnologyRti Surgical, Inc.201711—
+4K170953Tomcat Cervical Spinal SystemChoicespine, LP2017103—
+4K162236Ax Stand-Alone ALIF SystemInnovasis, Inc.201774—
+4K170055CAPRI Corpectomy Cage SystemK2m201711—
+4K163230NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2017276—
+4K170455MectaLIF Anterior Stand AloneMedacta International S.A.20174—
+4K163364MOJAVE Expandable Interbody SystemK2m201725—
+4K163474CAVUX CervicalCage-L SA SystemProvidence Medical Technology, Inc.20170—
+4K162918Atlas Spine Expandable Interbody SystemAtlas Spine, Inc.201729—
+4K160976Altus Spine Interbody Fusion SystemAltus Partners, LLC20178—
+4K163180Hubble IIOrbbo Surgical, LLC20160—
+4K162327COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL2016111—
+4K160222OIC Cervical PEEK SpacerThe Orthopaedic Implant Company20160—
+4K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation201679—
+4K162103Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine…Choicespine, LP2016161—
+4K162431Luna 3D Interbody Fusion SystemBenvenue Medical, Inc.20163—
+4K160924Amendia Interbody Fusion DevicesAmendia, Inc.2016166—
+4K162358T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution SystemSynthes USA Products, LLC2016127—
+4K160074Rampart D Lumbar Interbody Fusion DeviceSpineology, Inc.20165—
+4K161442NuVasive® CoRoent® Small Interlock™ SystemNu Vasive, Incorporated201694—
+4K161173Avenue® T TLIF CageLdr Spine USA, Inc.20163—
+4K162264Cascadia Interbody SystemK2m, Inc.2016169—
+4K161888JULIET® LL Lateral Lumbar CageSpineart2016145—
+4K161485Nanovis Intervertebral Body Fusion System and Forticore (R)Nanovis, LLC20165—
+4K161230NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated2016381—
+4K161210RIALTO (TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC (TM)…Medtronic Sofamor Danek201679—
+4K161223TransContinental® M Spacers and InterContinental® Plate-SpacersGlobus Medical, Inc.2016117—
+4K153786Prow Fusion-VNlt Spine, Ltd.20166—
+4K160916CoRoent® Ti-C SystemNu Vasive, Incorporated2016139—
+4K153107Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine VEO™…Choicespine, LP2016171—
+4K160125Cascadia Interbody SystemK2m2016315—
+4K160547Cascadia Interbody SystemK2m2016157—
+4K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+4K153627NuVasive® TLX Interbody SystemNu Vasive, Incorporated2016252—
+4K153250Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies201632—
+4K151406Cogent Lateral Interbody SystemCogent Spine, LLC201611—
+4K160291Optimus ALIF SystemAmendia, Inc.20160—
+4K153442CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with…Medtronic Sofamor Danek USA, Inc.201684—
+4K151726AVS AL and AVS ALign PEEK Spacers, AVS PL and AVS UniLIF PEEK Spacers, AVS TL PEEK…Stryker Corporation20161391
+4K151312VerteLP Interbody Fusion DeviceVgi, LLC201601
+4K151773CONCORDE Bullet Lumbar Interbody SystemMedos International SARL2015201—
+4K152304Tritanium PL CageStryker20154481
+4K152259InFill Interbody Fusion DevicePinnacle Spine Group, LLC20152—
+4K150788Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral Body Fusion…Meditech Spine, LLC2015202—
+4K151785Px HA PEEK IBF SystemInnovasis, Inc.201557—
+4K151408LOSPA IS Spinal SystemCorentec Co., Ltd.20151—
+4K151472NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated2015479—
+4K151322Amendia Interbody Fusion DevicesAmendia, Inc.20152261
+4K151140LnK Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.201529—
+4K150994NuVasive CoRoent Thoracolumbar ImplantsNu Vasive, Incorporated2015402—
+4K150362NuVasive CoRoent Small Interbody SystemNu Vasive, Incorporated2015441—
+4K142744Mecta-C TiPEEKMedacta International201512—
+4K143595NuVasive (R) CCX-L Interbody SystemNu Vasive, Incorporated2015253—
+4K143258PLIF STS, TLIF STS, OLIF STS (Spinal Truss System)4Web, Inc.2015211—
+4K150206InFill Interbody Fusion DevicesPinnacle Spine Group, LLC20152—
+4K143616AccuLIF TL and PL CageStryker Corporation20154694
+4K143228Ancora LLC Interbody Fusion DeviceFrontier Medical Devices, Inc.20150—
+4K143214SCARLET® AC-T Secured Anterior Cervical CageSpineart20153—
+4K143126Renovis S141 Lumbar Interbody Cage SystemRenovis Surgical Technologies2015237—
+4K142940Endoskeleton TCS SystemTitan Spine, LLC20151112
+4K142299CoRoent Small Interlock SystemNu Vasive, Incorporated201499—
+4K141896Coroent SystemNu Vasive, Incorporated2014480—
+4K142050Nuvasive Coroent Small Contoured Interbody SystemNu Vasive, Incorporated2014449—
+4K142193Cogent Med-Lif XLCogent Spine, LLC201412—
+4K140577Innesis Peek TL CageBk Meditech, Co., Ltd.20142—
+4K141314Scarlet AC-T Secured Anterior Cervical Cage and Associated InstrumentationSpineart201438—
+4K133577Clydesdale (R) Spinal SystemMedtronic Sofamor Danek USA, Inc.2014256—
+4K140280ForticoreNanovis, LLC20149—
+4K140921Coroent Small Interbody SystemNu Vasive, Incorporated2014444—