510(k) Report

Devices descending from K023570

1,383 later devices reach Modification to Verte-Stack Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K180519HARRIER-SA™ Lumbar Interbody SystemChoicespine, LP20180—
+4K173892NuVasive® XLX Interbody SystemNu Vasive, Incorporated2018115—
+4K180078Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF SystemInnovasis, Inc.2018551
+4K172105The Plateau-LO Spacer SystemLife Spine, Inc.20181—
+4K171848FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO…Globus Medical, Inc.201755—
+4K172349InFill® Interbody Fusion DevicePinnacle Spine Group, LLC20171—
+4K170389TAURUS PEEK Cage SystemMedyssey USA, Inc.20170—
+4K172676NuVasive® Modulus-C Interbody SystemNu Vasive, Incorporated2017125—
+4K172328SOVEREIGN™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201730—
+4K172123NuVasive® Modulus XLIF Interbody SystemNu Vasive, Incorporated2017227—
+4K171689ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2017109—
+4K163366Shanghai Sanyou CARMEN Cervical Fusion SystemShanghai Sanyou Medical Co, Ltd.20170—
+4K170119Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc.201711
+4K171107CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal SystemMedtronic Sofamor Danek USA, Inc.20178—
+4K172199ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT…Medtronic Sofamor Danek20176—
+4K163422Shanghai Sanyou PEEK Cage SystemShanghai Sanyou Medical Co, Ltd.20173—
+4K171140Matrixx SystemNexxt Spine, LLC2017145—
+4K171656Genesys Spine Apache Interbody Fusion SystemGenesys Spine20170—
+4K171046SeaSpine Cambria SystemSeaSpine Orthopedics Corporation201762—
+4K171031CRESCENT™ Spinal SystemMedtronic Sofamor Danek2017144—
+4K171468FUSE Spinal SystemMedtronic Sofamor Danek20170—
+4K162496Foundation 3D InterbodyCorelink, LLC201782—
+4K170243LOSPA IS TLIF & DLIF CagesCorentec Co., Ltd.20170—
+4K162680SOVEREIGN® Spinal SystemMedtronic Sofamor Danek USA, Inc.201631—
+4K162327COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL2016111—
+4K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation201679—
+4K160924Amendia Interbody Fusion DevicesAmendia, Inc.2016166—
+4K161438Genesys Spine Apache® Anterior Lumbar Interbody Fusion SystemGenesys Spine201611—
+4K153665Prow Fusion-LNlt Spine, Ltd.20160—
+4K160958Battalion Universal Spacer SystemAlphatec Spine2016114—
+4K161230NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated2016381—
+4K161404Genesys Spine Apache® Lateral Lumbar Interbody Fusion SystemGenesys Spine201610—
+4K153621Juliet® TiSpineart2016751
+4K160916CoRoent® Ti-C SystemNu Vasive, Incorporated2016139—
+4K153436LATERAL Spine Truss System4Web, Inc.20165—
+4K153419NuVasive CoRoent Thoracolumbar SystemNu Vasive, Incorporated2016400—
+4K151665SUSTAIN Additional ImplantsGlobus Medical, Inc.2016119—
+4K153438PERIMETER C (Titanium) Spinal SystemMedtronic Sofamor Danek USA, Inc.20160—
+4K153373CORNERSTONE PSR Cervical Fusion System, PERIMETER C Spinal System, PEEK PREVAIL Cervical…Medtronic Sofamor Danek2016110—
+4K143479Bluefin Interbody SystemTides Medical20152—
+4K151538NuVasive PEEK Corpectomy Railed SystemNu Vasive, Incorporated201513—
+4K151167NuVasive PEEK Corpectomy SystemNu Vasive, Incorporated201513—
+4K150673SYNFIX Evolution Secured Spacer SystemSynthes (USA) Products, LLC2015137—
+4K151056Aesculap T-Space PEEK and XP Spinal SystemAesculap Implant Systems, LLC20150—
+4K150847Foundation Interbody DevicesCorelink, LLC201529—
+4K150321EVOS Lumbar Interbody SystemCutting Edge Spine, LLC201592—
+4K150135DIVERGENCE-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc.2015228—
+4K142559ELEVATE Spinal SystemMedtronic Sofamor Danek USA, Inc.2015130—
+4K141599Divergence Anterior Cervical Fusion SystemMedtronic Sofamor Danek USA, Inc.201516—
+4K133827A-Link ZOsteo Vasive, LLC2014262
+4K142277Juliet POSpineart2014119—
+4K140577Innesis Peek TL CageBk Meditech, Co., Ltd.20142—
+4K140563Lateral VBR SystemNu Vasive, Incorporated20140—
+4K140864Veloxtm Interbody Fusion SystemU&I Corp.20149—
+4K140417Divergence Mini-Plate Anterior Cervical Fusion SystemMedtronic Sofamor Danek, Inc.201411—
+4K141376Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx, Struxxure Anterior…Nexxt Spine, LLC2014106—
+4K123607Octane Elevate Spinal Implant SystemExactech, Inc.20141—
+4K140474Juliet OLSpineart2014120—
+4K132483Innesis Peek Cervical CageBk Meditech, Co., Ltd.20140—
+4K133529Camber Spine Coveris Cervical CageCamber Spine201410—
+4K133893Sterispine LC CageSafe Orthopaedics20141—
+4K133205Capstone PTC Spinal System, Clydesdale PTC Spinal SystemMedtronic Sofamor Danek USA, Inc.2014124—
+4K132926Velofixtm Interbody Fusion SystemU&I Corp.201410—
+4K133192Mectalif TipeekMedacta International201416—
+4K132894Optio-C Anterior Cervical SystemZimmer Spine, Inc.201424—
+4K131276Lateral SynfixSynthes (USA) Products, LLC2014146—
+4K133650Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2013344—
+4K132584Perimeter C Spinal SystemMedtronic Sofamor Danek USA, Inc.2013119—
+4K133216Crescent Spinal SystemMedtronic Sofamor Danek, Inc.201392—
+4K130853Idys (TM) CClariance20132—
+4K131669Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek USA, Inc.2013234—
+4K123027Capstone (R) Spinal SystemMedtronic Sofamor Danek, Inc.2013709—
+4K131077Life Spine Plateau Spacer SystemLife Spine201310—
+4K124034Mectalif AnteriorMedacta International201311—
+4K123978Capstone L Spinal SystemMedtronic Sofamor Danek USA201313—
+4K122989Biomet Lateral Spacer SystemBiomet Spine (Aka Ebi, LLC)2012171—
+4K121567Oracle Lumbar Intervertebral Body Fusion Cage SystemAccel Spine20125—
+4K122591Clydesdale Spinal SystemMedtronic Sofamor Danek, Inc.201214—
+4K122444Cervical CageEisertech, LLC201222—
+4K121760Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2012723—
+4K121096Venus Lumbar Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd.201236—
+4K120275Synthes Acis/Vertebral Spacer CRSynthes (Usa), LLC2012173—
+4K120063Venus Lumbar Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd.201237—
+4K112862Mecta-CMedacta International201114—
+4K112444Anatomic Peek Cervical Fusion SystemMedtronic Sofamor Danck USA, Inc.2011324—
+4K110442Nanovis Intervertebral Body Fusion SystemNanovis, LLC201110—
+4K110783Venus Interbody Fixation System- Venus Plif/Tlif, Alif Peek CageL&K BIOMED Co., Ltd.201138—
+4K112756Fortify (TM) and Fortify (TM)-R Corpectomy SpacersGlobus Medical, Inc.2011268—
+4K102315Staxx XDL SystemSpine Wave, Inc.20113—
+4K110543Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc.2011808—
+4K100967Perimeter C Spinal SystemMedtronic Sofamor Danek USA, Inc.2011121—
+4K111469Staxxsd SystemSpine Wave, Inc.20110—
+4K100976T2 XVBR 1.5 Spinal SystemMedtronic Sofamor Danek USA, Inc.201049—
+4K101812Construx Mini Peek Spacer SystemOrthofix, Inc.2010291—
+4K091946Vlift-S Vertebral Body Replacement System, Models 488812XX, 488814XX, 488816XX, 488818XXStryker Spine20095—
+4K091883T2 Spinal SystemMedtronic Sofamor Danek USA, Inc.200951—
+4K090315Staxx XD SystemSpine Wave, Inc.20096—
+4K083311Aesculap Cespace Peek Intervertebral Body Fusion SystemAesculap Implant Systems, Inc.2009554—
+4K082732Modification to: Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2008710—
+4K081849Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc.20087531