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
+1K214010Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA202249—
+1K172328SOVEREIGN™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201730—
+1K150135DIVERGENCE-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc.2015228—
+1K111820Synster Cervical Cage, Alif Cage, Plif Cage, Ptlif Cage, Tlif CageBm Korea Co., Ltd.201220—
+1K110562Telamon Peek Spinal SystemMedtronic Sofamor Danek USA2011306—
+1K103034Genesys Spine Interbody Fusion SystemGenesys Spine20101371
+1K100042Difusion Technologies Xiphos Interbody Fusion SystemDifusion Technologies2010864—
+1K094025Crescent Spinal SystemMedtronic Sofamor Danek2010838—
+1K090353Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek2009796—
+1K091122Diana Fusion CageSignus Medical20090—
+1K083714Endoskeleton TT Interbody Fusion Device (Ibd)Titan Spine, LLC2009412—
+1K090064Eminent Spine Interbody Fusion SystemEminent Spine20097011
+1K090376Spinesmith Cynch Spinal SystemSpine Smith Partners L.P.2009476—
+1K080615Endoskeleton TA Interbody Fusion Device (Ibd)Titan Spine, LLC2008564—
+1K073109Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd.2008907—
+1K073291Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.20081,103—
+1K080058Turbo Prime Ibd SystemSpineselect, LLC20081—
+1K080083Intrepid Spinal SystemMedtronic Sofamor Danek20089328
+1K072226Impix SpacerMedicrea Technologies2007812—
+2K261408SABER-XA SystemElevation Spine20260—
+2K260810Anteralign LS coverplateTyber Medical, LLC20260—
+2K241992Catalyft™ LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.20240—
+2K242267Gemini Medical Cage SystemZheJiang Decans Medical Devices Co., Ltd.20241—
+2K230219Eminent Spine 3D Lumbar Interbody Fusion SystemsEminent Spine, LLC20234—
+2K223776PEEK Spinal Infusion CageChangzhou Geasure Medical Apparatus and Instruments Co., Ltd.20230—
+2K223146EVOLUTION SPINE Interbody SystemEvolution Spine20239—
+2K212701Eminent Spine 3D Cervical Interbody Fusion SystemEminent Spine20235—
+2K223494CD Horizon Spinal SystemMedtronic202317—
+2K223153Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.20220—
+2K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+2K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20227—
+2K212524Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.202155—
+2K212653Catalyft LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.202127
+2K211769OneLIF Intervertebral Body Replacement SystemNovapproach Spine202112
+2K210425Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.2021561
+2K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+2K201287Impulse Interbody Fusion SystemDegen Medical20208—
+2K201145X-Pac Expandable Lumbar Cage SystemExpanding Innovations, Inc.20204—
+2K201267Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek202079—
+2K201585Monterey AL Interbody SystemStryker Corporation202044
+2K191788CAPSTONE Spinal System, CLYDESDALE PTC Spinal System, CRESCENT Spinal System, CRESCENT…Medtronic Sofamor Danek USA, Inc.20200—
+2K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+2K191581Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion…Titan Spine, Inc.202081—
+2K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine20207—
+2K191796Neo Cage SystemNeo Medical SA20190—
+2K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20199—
+2K190544XIHPOS™ ZFUZE™ Interbody Fusion SystemDifusion Technologies20190—
+2K1803473d CageFims Co., Ltd.20190—
+2K191066CD Horizon™ Astute™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201921—
+2K190398Republic Spine Restore Intervertebral Body Fusion SystemRepublic Spine, LLC20190—
+2K190889Republic Spine Restore Cervical Interbody Fusion SystemRepublic Spine, LLC20190—
+2K190165Capstone Control™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20196—
+2K181048Neo Cage System TMNeo Medical SA20191—
+2K180228II-Type Intervertebral SpacerPaonan Biotech Co., Ltd.20191—
+2K181295Genesys Spine AIS-C Cervical Stand-Alone SystemGenesys Spine201817—
+2K173947Lumbar Interbody Fusion System (OLLIF)Advanced Research Medical, LLC201801
+2K173606SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu…SeaSpine Orthopedics Corporation201859—
+2K180056Genesys Spine AIS-C Cervical Anchored Interbody SystemGenesys Spine201818—
+2K172320Neurostructures Cavetto® Cervical Cage SystemNeurostructures, Inc.20183—
+2K172330Blustone Synergy Silica SystemBlustone Synergy20170—
+2K163595IMPIX 3D Print CagesMedicrea International SA2017282
+2K172083Idys™ ALIF SystemClariance, Sas20177—
+2K171689ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2017109—
+2K171107CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal SystemMedtronic Sofamor Danek USA, Inc.20178—
+2K172199ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT…Medtronic Sofamor Danek20176—
+2K163422Shanghai Sanyou PEEK Cage SystemShanghai Sanyou Medical Co, Ltd.20173—
+2K171893Blustone Synergy Lumbar Interbody Fusion System (Basalt, Magma, Obsidian), Blustone…Bluestone Synergy20172—
+2K170851Anterior Spine Truss System (STS) Interbody Fusion Device4Web, Inc.20175—
+2K171656Genesys Spine Apache Interbody Fusion SystemGenesys Spine20170—
+2K171031CRESCENT™ Spinal SystemMedtronic Sofamor Danek2017144—
+2K163494Summit Spine Channel Cervical Interbody Fusion SystemSummit Spine20171—
+2K162212Divergence-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc.201757—
+2K163481HALF DOME Posterior Lumbar Interbody SystemAstura Medical201731—
+2K170592NuVasive BASE Interfixated Titanium SystemNu Vasive, Incorporated2017186—
+2K163269Endoskeleton (R) TAS Interbody Fusion Device / Endoskeleton (R) TAS Hyperlordotic…Titan Spine, LLC2017143—
+2K162680SOVEREIGN® Spinal SystemMedtronic Sofamor Danek USA, Inc.201631—
+2K161993Leva® Anterior Interbody SystemSpine Wave, Inc.20160—
+2K160663Lumbar Interbody Fusion System (ALIF, PLIF, LLIF, TPLIF)Evolution Spine, LLC20160—
+2K161438Genesys Spine Apache® Anterior Lumbar Interbody Fusion SystemGenesys Spine201611—
+2K161404Genesys Spine Apache® Lateral Lumbar Interbody Fusion SystemGenesys Spine201610—
+2K160874Nanovis Intervertebral Body Fusion System and FortiCore®Nanovis, LLC20164—
+2K160324Cervical Interbody Fusion SystemEvolution Spine, LLC20162—
+2K153123Genesys Spine Apache Interbody Fusion SystemGenesys Spine201612—
+2K160418PERIMETER Interbody Fusion DeviceMedtronic Sofamor Danek USA, Inc.20165—
+2K152943NuVasive Foundation-LL SystemNu Vasive, Incorporated2015187—
+2K152277PIVOX (tm) Oblique Lateral Spinal SystemMedtronic Sofamor Danek USA, Inc.2015190—
+2K151819Integrity Spine Lumbar Interbody Fusion SystemIntegrity Spine Lumbar Interbody Fusion System20154—
+2K150812Genesys Spine Apache Cervical Interbody Fusion SystemGenesys Spine201512—
+2K150847Foundation Interbody DevicesCorelink, LLC201529—
+2K150321EVOS Lumbar Interbody SystemCutting Edge Spine, LLC201592—
+2K151214ALIF Interfixated SystemNu Vasive, Incorporated2015220—
+2K142559ELEVATE Spinal SystemMedtronic Sofamor Danek USA, Inc.2015130—
+2K150643Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-TiCentinel Spine, Inc.2015368—
+2K140348Interbody CageEisertech, LLC2015235—
+2K141798Sypher Spacer SystemBiogennix, LLC20151—
+2K141187Impix Alif S/aMedicrea International SA201501
+2K142328nvcNvision Biomedical Technologies, LLC20144—
+2K142594nva, nvp, nvtNvision Biomedical Technologies, LLC20144—
+2K141333Arena-C Tifuse Cervical Intervertebral Body Fusion DeviceSpinefrontier, Inc.20140—
+2K133827A-Link ZOsteo Vasive, LLC2014262