510(k) Report

Devices descending from K062073

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K082732Modification to: Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2008710—
+1K073285Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek USA, Inc.2008637—
+2K210470C-CURVE Interbody Fusion DeviceMedicrea International SA20210—
+2K191788CAPSTONE Spinal System, CLYDESDALE PTC Spinal System, CRESCENT Spinal System, CRESCENT…Medtronic Sofamor Danek USA, Inc.20200—
+2K162531Sterispine CCSafe Orthopaedics20160—
+2K153373CORNERSTONE PSR Cervical Fusion System, PERIMETER C Spinal System, PEEK PREVAIL Cervical…Medtronic Sofamor Danek2016110—
+2K142218Coalition AGX Plate and Coalition AGX SpacerGlobus Medical, Inc.2015155—
+2K142940Endoskeleton TCS SystemTitan Spine, LLC20151112
+2K133494Chesapeake Spinal SystemK2m, Inc.2014330—
+2K123027Capstone (R) Spinal SystemMedtronic Sofamor Danek, Inc.2013709—
+2K122037Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion System Peek Prevail…Medtronic Sofamor Danek, Inc.2013281—
+2K120275Synthes Acis/Vertebral Spacer CRSynthes (Usa), LLC2012173—
+2K112459Synthes Zero-PSynthes Spine Co.Lp2011277—
+2K112068Synthes Zero-P Variable Angle (VA)Synthes Spine Co.Lp2011331
+2K100967Perimeter C Spinal SystemMedtronic Sofamor Danek USA, Inc.2011121—
+2K102323Cervical Standalone Intervertebral Body Fusion DeviceTheken Spine, LLC201062—
+2K094042Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek2010397—
+2K100214Cornerstone PSR Cervical Interbody Fusion DeviceMedtronic Sofamor Danek2010389—
+3K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+3K253213SAGI Cervical Cage SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+3K250764SpineLinc Anterior Cervical Implant SystemLincotek Medical20250—
+3K250769Dakota LP SystemPrecision Spine, Inc.20250—
+3K242195Gemini Cervical Fusion Cage SystemZheJiang Decans Medical Devices Co., Ltd.20241—
+3K231739Cervical Spine Truss System (CSTS)4Web Medical, Inc.20232—
+3K220334MONET Anterior Cervical Plate SystemCtl Medical Corporation20220—
+3K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+3K214010Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA202249—
+3K212266FIX-C PEEK Anterior Cervical Interbody SystemJeil Medical Corporation20217—
+3K212524Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.202155—
+3K200458Tailored-C Cervical Interbody Fusion SystemBespoke Technologies20203—
+3K201267Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek202079—
+3K192906Mecta-C Stand AloneMedacta International S.A.20201—
+3K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+3K192208CORNICE Cervical Spacer SystemLegend Spine Technologies20190—
+3K191243HEDRON Cervical SpacersGlobus Medical, Inc.201936—
+3K190885Elevation Spine Saber-C SystemElevation Spine201925—
+3K191565Endoskeleton TCS Interbody Fusion DeviceTitan Spine, Inc.201901
+3K180909REVEL SpacersGlobus Medical, Inc.201837—
+3K181140Axis Chena Cervical PEEK Spacer SystemAxis Orthopaedics20182—
+3K181229TirboLOX-C Cervical IBFDCaptiva Spine, Inc.20180—
+3K180364HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC2018106—
+3K173722PATRIOT COLONIAL Spacer, SUSTAIN SpacerGlobus Medical, Inc.201894—
+3K172320Neurostructures Cavetto® Cervical Cage SystemNeurostructures, Inc.20183—
+3K172926SeaSpine Vu cPOD, Zuma-C, Complete CervicalSeaSpine Orthopedics Corporation201761—
+3K172185Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20177—
+3K173115COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and…Globus Medical, Inc.201783—
+3K172019Brisbane ALIF Device, Gladstone ALIF DeviceSignature Orthopaedics Pty, Ltd.20170—
+3K172328SOVEREIGN™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201730—
+3K163366Shanghai Sanyou CARMEN Cervical Fusion SystemShanghai Sanyou Medical Co, Ltd.20170—
+3K171689ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2017109—
+3K172065Scarlet AC-TSpineart20172—
+3K171107CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal SystemMedtronic Sofamor Danek USA, Inc.20178—
+3K163422Shanghai Sanyou PEEK Cage SystemShanghai Sanyou Medical Co, Ltd.20173—
+3K170318NeoFuse Ti3D PLIF/TLIF/Cervical InterbodyHt Medical, LLC201749—
+3K152022SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION®…Globus Medical, Inc.2017149—
+3K1624024CIS® Marlin ACIF Cage SystemSolco Biomedical Co., Ltd.20171—
+3K162327COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL2016111—
+3K160125Cascadia Interbody SystemK2m2016315—
+3K152793Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.201629—
+3K153122Endoskeleton (r) TCS SystemTitan Spine, LLC20151061
+3K151773CONCORDE Bullet Lumbar Interbody SystemMedos International SARL2015201—
+3K151596Endoskeleton TCS Interbody Fusion DeviceTitan Spine, LLC20151101
+3K151408LOSPA IS Spinal SystemCorentec Co., Ltd.20151—
+3K150135DIVERGENCE-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc.2015228—
+3K142559ELEVATE Spinal SystemMedtronic Sofamor Danek USA, Inc.2015130—
+3K142487Chesapeake Stabilization SystemK2m, Inc.201571
+3K143616AccuLIF TL and PL CageStryker Corporation20154694
+3K143214SCARLET® AC-T Secured Anterior Cervical CageSpineart20153—
+3K141599Divergence Anterior Cervical Fusion SystemMedtronic Sofamor Danek USA, Inc.201516—
+3K141896Coroent SystemNu Vasive, Incorporated2014480—
+3K141314Scarlet AC-T Secured Anterior Cervical Cage and Associated InstrumentationSpineart201438—
+3K133577Clydesdale (R) Spinal SystemMedtronic Sofamor Danek USA, Inc.2014256—
+3K140417Divergence Mini-Plate Anterior Cervical Fusion SystemMedtronic Sofamor Danek, Inc.201411—
+3K133205Capstone PTC Spinal System, Clydesdale PTC Spinal SystemMedtronic Sofamor Danek USA, Inc.2014124—
+3K133645Perimeter C Spinal System, Capstone Spinal System, Capstone L Spinal System, Perimeter…Medtronic Sofamor Danek USA, Inc.20146—
+3K133650Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2013344—
+3K132584Perimeter C Spinal SystemMedtronic Sofamor Danek USA, Inc.2013119—
+3K130853Idys (TM) CClariance20132—
+3K131449Coalition SpacerGlobus Medical, Inc.2013235—
+3K121852Synthes Zero-P Variable Angle (VA)Synthes Spine Co.Lp201230—
+3K113252Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek2012306—
+3K112388Lanx Cervical SALanx, Inc.201126—
+3K112444Anatomic Peek Cervical Fusion SystemMedtronic Sofamor Danck USA, Inc.2011324—
+3K110442Nanovis Intervertebral Body Fusion SystemNanovis, LLC201110—
+3K111264Cornerstone (R) PSR Cervical Fusion SystemMedtronic Sofamor Danek USA2011331—
+3K102547Coroent Interlock SystemNuvasive, Inc.2011131—
+4K261408SABER-XA SystemElevation Spine20260—
+4K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+4K260810Anteralign LS coverplateTyber Medical, LLC20260—
+4K260660SABER-C SystemElevation Spine20261—
+4K253260ORIO-3D Cage SystemSpineCraft20260—
+4K242303MOD-COrthomod, LLC20260—
+4K254017SWINGO-3D Lumbar Cage SystemImplanet20260—
+4K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+4K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+4K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+4K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.20250—
+4K250560BEE HANGMedical GmbH20250—
+4K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—
+4K250540SABER-C SystemElevation Spine20252—