510(k) Report

Devices descending from K043561

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K082342Modification to Capstone Spinal SystemMedtronic Sofamor Danek2008716—
+1K060719Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2006992—
+2K191788CAPSTONE Spinal System, CLYDESDALE PTC Spinal System, CRESCENT Spinal System, CRESCENT…Medtronic Sofamor Danek USA, Inc.20200—
+2K191796Neo Cage SystemNeo Medical SA20190—
+2K181048Neo Cage System TMNeo Medical SA20191—
+2K140864Veloxtm Interbody Fusion SystemU&I Corp.20149—
+2K132926Velofixtm Interbody Fusion SystemU&I Corp.201410—
+2K082732Modification to: Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2008710—
+2K063491T2 Sceptor Spinal SystemMedtronic Sofamor Danek200753—
+2K062133Modification to Verte-Stack Spinal SystemMedtronic Spinal and Biologics Div2006649—
+2K062073Verte-Stack Spinal SystemMedtronic Sofamor Danek2006844—
+2K061938Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc.2006152—
+3K252351UniSpace® TPLIF CageCg Medtech Co., Ltd.20250—
+3K183243Velofix TLIF CageU&I Corporation20190—
+3K172419Velofix™ TLIF CageU&I Corporation20172—
+3K171749Velofix (tm) Interbody Fusion SystemU&I Corporation20175—
+3K123027Capstone (R) Spinal SystemMedtronic Sofamor Danek, Inc.2013709—
+3K091883T2 Spinal SystemMedtronic Sofamor Danek USA, Inc.200951—
+3K073285Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek USA, Inc.2008637—
+3K071033T2 XVBR Spinal SystemMedtronic Sofamor Danek200750—
+3K070173Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc.2007648—
+3K062427Verte-Stack Spinal SystemMedtronic Sofamor Danek2006151—
+4K214010Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA202249—
+4K212524Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.202155—
+4K201793EDEN Peek CageJmt Co., Ltd.20210—
+4K210470C-CURVE Interbody Fusion DeviceMedicrea International SA20210—
+4K201267Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek202079—
+4K192214CarboClear VBR SystemCarboFix Orthopedics, Ltd.20191—
+4K183197PYRAMESH™ Implant SystemMedtronic Sofamor Danek USA, Inc.20190—
+4K190067Velofix Interbody Fusion SystemU&I Corporation20193—
+4K183510T2 STRATOSPHERE Expandable Corpectomy SystemMedtronic Sofamor Danek USA, Inc.201927—
+4K181829Velofix TLIF CageU&I Corporation20181—
+4K173125T2 STRATOSPHERE™ Expandable Corpectomy SystemMedtronic Sofamor Danek201747—
+4K171689ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2017109—
+4K162531Sterispine CCSafe Orthopaedics20160—
+4K162327COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL2016111—
+4K153373CORNERSTONE PSR Cervical Fusion System, PERIMETER C Spinal System, PEEK PREVAIL Cervical…Medtronic Sofamor Danek2016110—
+4K151773CONCORDE Bullet Lumbar Interbody SystemMedos International SARL2015201—
+4K151538NuVasive PEEK Corpectomy Railed SystemNu Vasive, Incorporated201513—
+4K151167NuVasive PEEK Corpectomy SystemNu Vasive, Incorporated201513—
+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—
+4K133577Clydesdale (R) Spinal SystemMedtronic Sofamor Danek USA, Inc.2014256—
+4K133494Chesapeake Spinal SystemK2m, Inc.2014330—
+4K133205Capstone PTC Spinal System, Clydesdale PTC Spinal SystemMedtronic Sofamor Danek USA, Inc.2014124—
+4K133645Perimeter C Spinal System, Capstone Spinal System, Capstone L Spinal System, Perimeter…Medtronic Sofamor Danek USA, Inc.20146—
+4K133650Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2013344—
+4K131888T2 XVBR Spinal System, T2 Altitude Expandable Corpectomy DeviceMedtronic Sofamor Danek, Inc.20130—
+4K122037Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion System Peek Prevail…Medtronic Sofamor Danek, Inc.2013281—
+4K120275Synthes Acis/Vertebral Spacer CRSynthes (Usa), LLC2012173—
+4K112459Synthes Zero-PSynthes Spine Co.Lp2011277—
+4K112444Anatomic Peek Cervical Fusion SystemMedtronic Sofamor Danck USA, Inc.2011324—
+4K112068Synthes Zero-P Variable Angle (VA)Synthes Spine Co.Lp2011331
+4K100967Perimeter C Spinal SystemMedtronic Sofamor Danek USA, Inc.2011121—
+4K102323Cervical Standalone Intervertebral Body Fusion DeviceTheken Spine, LLC201062—
+4K100976T2 XVBR 1.5 Spinal SystemMedtronic Sofamor Danek USA, Inc.201049—
+4K094042Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek2010397—
+4K100214Cornerstone PSR Cervical Interbody Fusion DeviceMedtronic Sofamor Danek2010389—
+4K070742Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek2007150—
+5K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+5K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+5K260810Anteralign LS coverplateTyber Medical, LLC20260—
+5K253213SAGI Cervical Cage SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+5K250764SpineLinc Anterior Cervical Implant SystemLincotek Medical20250—
+5K250769Dakota LP SystemPrecision Spine, Inc.20250—
+5K250669Adaptix™ Interbody System with Titan nanoLOCK™ Surface TechnologyMedtronic Sofamor Danek USA, Inc.20250—
+5K242195Gemini Cervical Fusion Cage SystemZheJiang Decans Medical Devices Co., Ltd.20241—
+5K241992Catalyft™ LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.20240—
+5K241164IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic)202412
+5K241605Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spinal System…Nanovis, LLC20240—
+5K232345ATEC Posterior Navigated Disc Prep InstrumentsAlphatec Spine, Inc.20232—
+5K231739Cervical Spine Truss System (CSTS)4Web Medical, Inc.20232—
+5K222874CarboClear Cervical Cage System, CarboClear Cervical VBR SystemCarbofix Orthpedics, Ltd.20230—
+5K223494CD Horizon Spinal SystemMedtronic202317—
+5K223153Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.20220—
+5K220334MONET Anterior Cervical Plate SystemCtl Medical Corporation20220—
+5K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+5K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+5K213791Unispace SA Cervical CageEdisoninno Co., Ltd.20222—
+5K221180Anteralign (TM) Spinal System with Titan NanoLOCK Surface Technology Navigated InstrumentsMedtronic Sofamor Danek USA, Inc.20222—
+5K214011Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal…Medtronic Sofamor Danek USA, Inc.20221—
+5K212266FIX-C PEEK Anterior Cervical Interbody SystemJeil Medical Corporation20217—
+5K210425Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.2021561
+5K203683CarboClear Lumbar Cage SystemCarbofix Orthpedics, Ltd.20211—
+5K200458Tailored-C Cervical Interbody Fusion SystemBespoke Technologies20203—
+5K201193SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202018—
+5K192906Mecta-C Stand AloneMedacta International S.A.20201—
+5K193378CarboClear Lumbar Cage SystemCarboFix Orthopedics, Ltd.20202—
+5K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+5K192208CORNICE Cervical Spacer SystemLegend Spine Technologies20190—
+5K191066CD Horizon™ Astute™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201921—
+5K191243HEDRON Cervical SpacersGlobus Medical, Inc.201936—
+5K191039Navigated T2 STRATOSPHERE Inserters and Navigated TemplatesMedtronic Sofamor Danek USA, Inc.201918—
+5K190885Elevation Spine Saber-C SystemElevation Spine201925—
+5K191565Endoskeleton TCS Interbody Fusion DeviceTitan Spine, Inc.201901
+5K190959ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2019108—
+5K181096Avenue P Cage SystemZimmer Biomet Spine, Inc.20190—