510(k) Report

Devices descending from K030736

1,101 later devices reach Verte-Stack Spinal System, Extra Small Sizes through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K212524Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.202155—
+4K212562Idys-C ZP 3DTiClariance, SA20211—
+4K211689KEYSTONE PEEK Cage SystemShanghai Sanyou Medical Co, Ltd.20212—
+4K211769OneLIF Intervertebral Body Replacement SystemNovapproach Spine202112
+4K210470C-CURVE Interbody Fusion DeviceMedicrea International SA20210—
+4K210425Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.2021561
+4K200458Tailored-C Cervical Interbody Fusion SystemBespoke Technologies20203—
+4K202637F3D Corpectomy SystemCorelink, LLC20201—
+4K201267Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek202079—
+4K200235KONG-TL VBR System, KONG-C VBR SystemIcotec AG20201—
+4K200312Tryptik TiSpineart20202—
+4K200552EVOS Lumbar Interbody SystemCutting Edge Spine, LLC20200—
+4K191788CAPSTONE Spinal System, CLYDESDALE PTC Spinal System, CRESCENT Spinal System, CRESCENT…Medtronic Sofamor Danek USA, Inc.20200—
+4K193412NEXXT MATRIXX SystemNexxt Spine, LLC20201—
+4K191796Neo Cage SystemNeo Medical SA20190—
+4K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20199—
+4K192336Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.201917—
+4K191822Nano FortiCore, FortiCoreNanovis, LLC20192—
+4K192208CORNICE Cervical Spacer SystemLegend Spine Technologies20190—
+4K191066CD Horizon™ Astute™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201921—
+4K182885Atlantis™ Anterior Cervical Plate, Divergence™ Anterior Cervical Fusion System, Premier™…Medtronic Sofamor Danek USA, Inc.20198—
+4K181048Neo Cage System TMNeo Medical SA20191—
+4K180230NEST Interbody SystemPaonan Biotech Co., Ltd.20191—
+4K180909REVEL SpacersGlobus Medical, Inc.201837—
+4K181899Roccia® PlifSilony Medical GmbH20180—
+4K181357PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc.201897—
+4K182470Plateau Spacer SystemLife Spine20180—
+4K181140Axis Chena Cervical PEEK Spacer SystemAxis Orthopaedics20182—
+4K181818Scarlet AL-TSpineart201864—
+4K181229TirboLOX-C Cervical IBFDCaptiva Spine, Inc.20180—
+4K181203Juliet TiSpineart20181—
+4K180364HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC2018106—
+4K180674EVOL® ha-C Cervical Interbody Fusion SystemCutting Edge Spine, LLC20183—
+4K173722PATRIOT COLONIAL Spacer, SUSTAIN SpacerGlobus Medical, Inc.201894—
+4K172568CervagePrecifit Medical, Ltd.20181—
+4K180891EVOL Spinal Interbody System, EVOS Lumbar Interbody SystemCutting Edge Spine, LLC20181—
+4K180071STYLO Interbody Fusion DeviceLegend Spine Technologies20180—
+4K180851VERTEX™ Reconstruction SystemMedtronic Sofamor Danek USA, Inc.20188—
+4K172947HALF DOME Posterior Lumbar Interbody SystemAstura Medical201822—
+4K172320Neurostructures Cavetto® Cervical Cage SystemNeurostructures, Inc.20183—
+4K172816TiGer Shark™ SystemChoicespine, LP201859—
+4K173702Juliet Ti LLSpineart20182—
+4K172185Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20177—
+4K171848FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO…Globus Medical, Inc.201755—
+4K172349InFill® Interbody Fusion DevicePinnacle Spine Group, LLC20171—
+4K163595IMPIX 3D Print CagesMedicrea International SA2017282
+4K172083Idys™ ALIF SystemClariance, Sas20177—
+4K172328SOVEREIGN™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201730—
+4K171689ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2017109—
+4K172065Scarlet AC-TSpineart20172—
+4K163422Shanghai Sanyou PEEK Cage SystemShanghai Sanyou Medical Co, Ltd.20173—
+4K163375INFINITY™ OCT SystemMedtronic Sofamor Danek USA, Inc.2017165
+4K171657ShurFit 2C Lumbar Interbody Fusion SystemPrecision Spine, Inc.20174—
+4K170851Anterior Spine Truss System (STS) Interbody Fusion Device4Web, Inc.20175—
+4K171656Genesys Spine Apache Interbody Fusion SystemGenesys Spine20170—
+4K170318NeoFuse Ti3D PLIF/TLIF/Cervical InterbodyHt Medical, LLC201749—
+4K171031CRESCENT™ Spinal SystemMedtronic Sofamor Danek2017144—
+4K162212Divergence-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc.201757—
+4K163670Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20173—
+4K170271NuVasive (r) Monolith Corpectomy SystemNu Vasive, Incorporated201712—
+4K1624024CIS® Marlin ACIF Cage SystemSolco Biomedical Co., Ltd.20171—
+4K162531Sterispine CCSafe Orthopaedics20160—
+4K162680SOVEREIGN® Spinal SystemMedtronic Sofamor Danek USA, Inc.201631—
+4K162327COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL2016111—
+4K161438Genesys Spine Apache® Anterior Lumbar Interbody Fusion SystemGenesys Spine201611—
+4K153665Prow Fusion-LNlt Spine, Ltd.20160—
+4K161485Nanovis Intervertebral Body Fusion System and Forticore (R)Nanovis, LLC20165—
+4K160631Keos Lumbar IBFDKeos20161—
+4K160874Nanovis Intervertebral Body Fusion System and FortiCore®Nanovis, LLC20164—
+4K153436LATERAL Spine Truss System4Web, Inc.20165—
+4K153615NeoFuse HA Enhanced PLIF/TLIFHt Medical, LLC201650—
+4K153438PERIMETER C (Titanium) Spinal SystemMedtronic Sofamor Danek USA, Inc.20160—
+4K151310Amendia Interbody Fusion DevicesAmendia, Inc.2016169—
+4K151773CONCORDE Bullet Lumbar Interbody SystemMedos International SARL2015201—
+4K152277PIVOX (tm) Oblique Lateral Spinal SystemMedtronic Sofamor Danek USA, Inc.2015190—
+4K151408LOSPA IS Spinal SystemCorentec Co., Ltd.20151—
+4K150673SYNFIX Evolution Secured Spacer SystemSynthes (USA) Products, LLC2015137—
+4K151128CAPSTONE Spinal System, CLYDESDALE Spinal SystemMedtronic Sofamor Danek USA, Inc.2015255—
+4K142645Avenue T TLIF CageLdr Spine USA, Inc.2015191—
+4K142559ELEVATE Spinal SystemMedtronic Sofamor Danek USA, Inc.2015130—
+4K142218Coalition AGX Plate and Coalition AGX SpacerGlobus Medical, Inc.2015155—
+4K143616AccuLIF TL and PL CageStryker Corporation20154694
+4K142940Endoskeleton TCS SystemTitan Spine, LLC20151112
+4K141896Coroent SystemNu Vasive, Incorporated2014480—
+4K142450DIVERGENCE Anterior Cervical Fusion SystemMedtronic Sofamor Danek USA, Inc.20146—
+4K133577Clydesdale (R) Spinal SystemMedtronic Sofamor Danek USA, Inc.2014256—
+4K140280ForticoreNanovis, LLC20149—
+4K140563Lateral VBR SystemNu Vasive, Incorporated20140—
+4K140864Veloxtm Interbody Fusion SystemU&I Corp.20149—
+4K133494Chesapeake Spinal SystemK2m, Inc.2014330—
+4K133205Capstone PTC Spinal System, Clydesdale PTC Spinal SystemMedtronic Sofamor Danek USA, Inc.2014124—
+4K132926Velofixtm Interbody Fusion SystemU&I Corp.201410—
+4K133557Juliet LL Lateral Lumbar CageSpineart2014147—
+4K131276Lateral SynfixSynthes (USA) Products, LLC2014146—
+4K131669Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek USA, Inc.2013234—
+4K131888T2 XVBR Spinal System, T2 Altitude Expandable Corpectomy DeviceMedtronic Sofamor Danek, Inc.20130—
+4K123978Capstone L Spinal SystemMedtronic Sofamor Danek USA201313—
+4K123656Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc.201339—
+4K122989Biomet Lateral Spacer SystemBiomet Spine (Aka Ebi, LLC)2012171—
+4K121567Oracle Lumbar Intervertebral Body Fusion Cage SystemAccel Spine20125—