510(k) Report

Devices descending from K060719

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K063491T2 Sceptor Spinal SystemMedtronic Sofamor Danek200753—
+1K062133Modification to Verte-Stack Spinal SystemMedtronic Spinal and Biologics Div2006649—
+1K062073Verte-Stack Spinal SystemMedtronic Sofamor Danek2006844—
+1K061938Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc.2006152—
+2K091883T2 Spinal SystemMedtronic Sofamor Danek USA, Inc.200951—
+2K082732Modification to: Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2008710—
+2K073285Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek USA, Inc.2008637—
+2K071033T2 XVBR Spinal SystemMedtronic Sofamor Danek200750—
+2K070173Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc.2007648—
+2K062427Verte-Stack Spinal SystemMedtronic Sofamor Danek2006151—
+3K210470C-CURVE Interbody Fusion DeviceMedicrea International SA20210—
+3K191788CAPSTONE Spinal System, CLYDESDALE PTC Spinal System, CRESCENT Spinal System, CRESCENT…Medtronic Sofamor Danek USA, Inc.20200—
+3K192214CarboClear VBR SystemCarboFix Orthopedics, Ltd.20191—
+3K183197PYRAMESH™ Implant SystemMedtronic Sofamor Danek USA, Inc.20190—
+3K183510T2 STRATOSPHERE Expandable Corpectomy SystemMedtronic Sofamor Danek USA, Inc.201927—
+3K173125T2 STRATOSPHERE™ Expandable Corpectomy SystemMedtronic Sofamor Danek201747—
+3K162531Sterispine CCSafe Orthopaedics20160—
+3K153373CORNERSTONE PSR Cervical Fusion System, PERIMETER C Spinal System, PEEK PREVAIL Cervical…Medtronic Sofamor Danek2016110—
+3K151538NuVasive PEEK Corpectomy Railed SystemNu Vasive, Incorporated201513—
+3K151167NuVasive PEEK Corpectomy SystemNu Vasive, Incorporated201513—
+3K142218Coalition AGX Plate and Coalition AGX SpacerGlobus Medical, Inc.2015155—
+3K142940Endoskeleton TCS SystemTitan Spine, LLC20151112
+3K133494Chesapeake Spinal SystemK2m, Inc.2014330—
+3K131888T2 XVBR Spinal System, T2 Altitude Expandable Corpectomy DeviceMedtronic Sofamor Danek, Inc.20130—
+3K123027Capstone (R) Spinal SystemMedtronic Sofamor Danek, Inc.2013709—
+3K122037Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion System Peek Prevail…Medtronic Sofamor Danek, Inc.2013281—
+3K120275Synthes Acis/Vertebral Spacer CRSynthes (Usa), LLC2012173—
+3K112459Synthes Zero-PSynthes Spine Co.Lp2011277—
+3K112444Anatomic Peek Cervical Fusion SystemMedtronic Sofamor Danck USA, Inc.2011324—
+3K112068Synthes Zero-P Variable Angle (VA)Synthes Spine Co.Lp2011331
+3K100967Perimeter C Spinal SystemMedtronic Sofamor Danek USA, Inc.2011121—
+3K102323Cervical Standalone Intervertebral Body Fusion DeviceTheken Spine, LLC201062—
+3K100976T2 XVBR 1.5 Spinal SystemMedtronic Sofamor Danek USA, Inc.201049—
+3K094042Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek2010397—
+3K100214Cornerstone PSR Cervical Interbody Fusion DeviceMedtronic Sofamor Danek2010389—
+3K070742Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek2007150—
+4K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+4K253213SAGI Cervical Cage SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+4K250764SpineLinc Anterior Cervical Implant SystemLincotek Medical20250—
+4K250769Dakota LP SystemPrecision Spine, Inc.20250—
+4K242195Gemini Cervical Fusion Cage SystemZheJiang Decans Medical Devices Co., Ltd.20241—
+4K231739Cervical Spine Truss System (CSTS)4Web Medical, Inc.20232—
+4K222874CarboClear Cervical Cage System, CarboClear Cervical VBR SystemCarbofix Orthpedics, Ltd.20230—
+4K220334MONET Anterior Cervical Plate SystemCtl Medical Corporation20220—
+4K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+4K214010Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA202249—
+4K212266FIX-C PEEK Anterior Cervical Interbody SystemJeil Medical Corporation20217—
+4K212524Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.202155—
+4K200458Tailored-C Cervical Interbody Fusion SystemBespoke Technologies20203—
+4K201267Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek202079—
+4K192906Mecta-C Stand AloneMedacta International S.A.20201—
+4K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+4K192208CORNICE Cervical Spacer SystemLegend Spine Technologies20190—
+4K191066CD Horizon™ Astute™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201921—
+4K191243HEDRON Cervical SpacersGlobus Medical, Inc.201936—
+4K191039Navigated T2 STRATOSPHERE Inserters and Navigated TemplatesMedtronic Sofamor Danek USA, Inc.201918—
+4K190885Elevation Spine Saber-C SystemElevation Spine201925—
+4K191565Endoskeleton TCS Interbody Fusion DeviceTitan Spine, Inc.201901
+4K180909REVEL SpacersGlobus Medical, Inc.201837—
+4K181140Axis Chena Cervical PEEK Spacer SystemAxis Orthopaedics20182—
+4K181328T2 STRATOSPHERE™ Expandable Corpectomy SystemMedtronic Sofamor Danek USA, Inc.201828—
+4K181229TirboLOX-C Cervical IBFDCaptiva Spine, Inc.20180—
+4K180364HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC2018106—
+4K173722PATRIOT COLONIAL Spacer, SUSTAIN SpacerGlobus Medical, Inc.201894—
+4K172568CervagePrecifit Medical, Ltd.20181—
+4K180851VERTEX™ Reconstruction SystemMedtronic Sofamor Danek USA, Inc.20188—
+4K172320Neurostructures Cavetto® Cervical Cage SystemNeurostructures, Inc.20183—
+4K172926SeaSpine Vu cPOD, Zuma-C, Complete CervicalSeaSpine Orthopedics Corporation201761—
+4K172185Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20177—
+4K173115COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and…Globus Medical, Inc.201783—
+4K172019Brisbane ALIF Device, Gladstone ALIF DeviceSignature Orthopaedics Pty, Ltd.20170—
+4K172328SOVEREIGN™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201730—
+4K163366Shanghai Sanyou CARMEN Cervical Fusion SystemShanghai Sanyou Medical Co, Ltd.20170—
+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—
+4K171107CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal SystemMedtronic Sofamor Danek USA, Inc.20178—
+4K163422Shanghai Sanyou PEEK Cage SystemShanghai Sanyou Medical Co, Ltd.20173—
+4K163375INFINITY™ OCT SystemMedtronic Sofamor Danek USA, Inc.2017165
+4K170318NeoFuse Ti3D PLIF/TLIF/Cervical InterbodyHt Medical, LLC201749—
+4K170271NuVasive (r) Monolith Corpectomy SystemNu Vasive, Incorporated201712—
+4K152022SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION®…Globus Medical, Inc.2017149—
+4K1624024CIS® Marlin ACIF Cage SystemSolco Biomedical Co., Ltd.20171—
+4K162327COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL2016111—
+4K160125Cascadia Interbody SystemK2m2016315—
+4K152793Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.201629—
+4K153122Endoskeleton (r) TCS SystemTitan Spine, LLC20151061
+4K151773CONCORDE Bullet Lumbar Interbody SystemMedos International SARL2015201—
+4K151596Endoskeleton TCS Interbody Fusion DeviceTitan Spine, LLC20151101
+4K151408LOSPA IS Spinal SystemCorentec Co., Ltd.20151—
+4K150135DIVERGENCE-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc.2015228—
+4K142559ELEVATE Spinal SystemMedtronic Sofamor Danek USA, Inc.2015130—
+4K142487Chesapeake Stabilization SystemK2m, Inc.201571
+4K143616AccuLIF TL and PL CageStryker Corporation20154694
+4K143214SCARLET® AC-T Secured Anterior Cervical CageSpineart20153—
+4K141599Divergence Anterior Cervical Fusion SystemMedtronic Sofamor Danek USA, Inc.201516—
+4K141896Coroent SystemNu Vasive, Incorporated2014480—
+4K141314Scarlet AC-T Secured Anterior Cervical Cage and Associated InstrumentationSpineart201438—
+4K133577Clydesdale (R) Spinal SystemMedtronic Sofamor Danek USA, Inc.2014256—
+4K140417Divergence Mini-Plate Anterior Cervical Fusion SystemMedtronic Sofamor Danek, Inc.201411—
+4K133205Capstone PTC Spinal System, Clydesdale PTC Spinal SystemMedtronic Sofamor Danek USA, Inc.2014124—