510(k) Report

Devices descending from K041197

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K111264Cornerstone (R) PSR Cervical Fusion SystemMedtronic Sofamor Danek USA2011331—
+1K100214Cornerstone PSR Cervical Interbody Fusion DeviceMedtronic Sofamor Danek2010389—
+1K052931Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2005993—
+2K242303MOD-COrthomod, LLC20260—
+2K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+2K183197PYRAMESH™ Implant SystemMedtronic Sofamor Danek USA, Inc.20190—
+2K173125T2 STRATOSPHERE™ Expandable Corpectomy SystemMedtronic Sofamor Danek201747—
+2K163366Shanghai Sanyou CARMEN Cervical Fusion SystemShanghai Sanyou Medical Co, Ltd.20170—
+2K153373CORNERSTONE PSR Cervical Fusion System, PERIMETER C Spinal System, PEEK PREVAIL Cervical…Medtronic Sofamor Danek2016110—
+2K141599Divergence Anterior Cervical Fusion SystemMedtronic Sofamor Danek USA, Inc.201516—
+2K140417Divergence Mini-Plate Anterior Cervical Fusion SystemMedtronic Sofamor Danek, Inc.201411—
+2K132584Perimeter C Spinal SystemMedtronic Sofamor Danek USA, Inc.2013119—
+2K130853Idys (TM) CClariance20132—
+2K122037Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion System Peek Prevail…Medtronic Sofamor Danek, Inc.2013281—
+2K120275Synthes Acis/Vertebral Spacer CRSynthes (Usa), LLC2012173—
+2K112444Anatomic Peek Cervical Fusion SystemMedtronic Sofamor Danck USA, Inc.2011324—
+2K110442Nanovis Intervertebral Body Fusion SystemNanovis, LLC201110—
+2K100967Perimeter C Spinal SystemMedtronic Sofamor Danek USA, Inc.2011121—
+2K071033T2 XVBR Spinal SystemMedtronic Sofamor Danek200750—
+2K070173Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc.2007648—
+2K063491T2 Sceptor Spinal SystemMedtronic Sofamor Danek200753—
+2K062073Verte-Stack Spinal SystemMedtronic Sofamor Danek2006844—
+2K061938Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc.2006152—
+2K060719Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2006992—
+3K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+3K242195Gemini Cervical Fusion Cage SystemZheJiang Decans Medical Devices Co., Ltd.20241—
+3K241164IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic)202412
+3K231739Cervical Spine Truss System (CSTS)4Web Medical, Inc.20232—
+3K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+3K212358Romero Cervical CageSpineup, Inc.20226—
+3K212266FIX-C PEEK Anterior Cervical Interbody SystemJeil Medical Corporation20217—
+3K212562Idys-C ZP 3DTiClariance, SA20211—
+3K210470C-CURVE Interbody Fusion DeviceMedicrea International SA20210—
+3K200458Tailored-C Cervical Interbody Fusion SystemBespoke Technologies20203—
+3K192214CarboClear VBR SystemCarboFix Orthopedics, Ltd.20191—
+3K191822Nano FortiCore, FortiCoreNanovis, LLC20192—
+3K192208CORNICE Cervical Spacer SystemLegend Spine Technologies20190—
+3K191039Navigated T2 STRATOSPHERE Inserters and Navigated TemplatesMedtronic Sofamor Danek USA, Inc.201918—
+3K182885Atlantis™ Anterior Cervical Plate, Divergence™ Anterior Cervical Fusion System, Premier™…Medtronic Sofamor Danek USA, Inc.20198—
+3K183510T2 STRATOSPHERE Expandable Corpectomy SystemMedtronic Sofamor Danek USA, Inc.201927—
+3K180909REVEL SpacersGlobus Medical, Inc.201837—
+3K181140Axis Chena Cervical PEEK Spacer SystemAxis Orthopaedics20182—
+3K181229TirboLOX-C Cervical IBFDCaptiva Spine, Inc.20180—
+3K181328T2 STRATOSPHERE™ Expandable Corpectomy SystemMedtronic Sofamor Danek USA, Inc.201828—
+3K180364HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC2018106—
+3K173722PATRIOT COLONIAL Spacer, SUSTAIN SpacerGlobus Medical, Inc.201894—
+3K172568CervagePrecifit Medical, Ltd.20181—
+3K172320Neurostructures Cavetto® Cervical Cage SystemNeurostructures, Inc.20183—
+3K172185Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20177—
+3K172328SOVEREIGN™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201730—
+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—
+3K1624024CIS® Marlin ACIF Cage SystemSolco Biomedical Co., Ltd.20171—
+3K161485Nanovis Intervertebral Body Fusion System and Forticore (R)Nanovis, LLC20165—
+3K160874Nanovis Intervertebral Body Fusion System and FortiCore®Nanovis, LLC20164—
+3K153438PERIMETER C (Titanium) Spinal SystemMedtronic Sofamor Danek USA, Inc.20160—
+3K151408LOSPA IS Spinal SystemCorentec Co., Ltd.20151—
+3K151538NuVasive PEEK Corpectomy Railed SystemNu Vasive, Incorporated201513—
+3K151167NuVasive PEEK Corpectomy SystemNu Vasive, Incorporated201513—
+3K150135DIVERGENCE-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc.2015228—
+3K142559ELEVATE Spinal SystemMedtronic Sofamor Danek USA, Inc.2015130—
+3K142450DIVERGENCE Anterior Cervical Fusion SystemMedtronic Sofamor Danek USA, Inc.20146—
+3K140280ForticoreNanovis, LLC20149—
+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—
+3K100976T2 XVBR 1.5 Spinal SystemMedtronic Sofamor Danek USA, Inc.201049—
+3K091883T2 Spinal SystemMedtronic Sofamor Danek USA, Inc.200951—
+3K082732Modification to: Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2008710—
+3K073285Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek USA, Inc.2008637—
+3K062133Modification to Verte-Stack Spinal SystemMedtronic Spinal and Biologics Div2006649—
+3K062427Verte-Stack Spinal SystemMedtronic Sofamor Danek2006151—
+4K261408SABER-XA SystemElevation Spine20260—
+4K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+4K253213SAGI Cervical Cage SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+4K254017SWINGO-3D Lumbar Cage SystemImplanet20260—
+4K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+4K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+4K253577IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)Medicrea International S.A.S. (Medtronic)20250—
+4K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.20250—
+4K250560BEE HANGMedical GmbH20250—
+4K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+4K243915FIX-C 3D Ti ACIF SystemJeil Medical Corporation20250—
+4K241992Catalyft™ LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.20240—
+4K241605Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spinal System…Nanovis, LLC20240—
+4K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—
+4K240699SCARLET® AC-TiSpineart SA20240—
+4K240715Idys® C ZP 3DTiClariance20240—
+4K230872Halis™ Lumbar Cage System, Lydia™ Anterior Lumbar Fusion System, Dica™ Direction…Shanghai Sanyou Medical Co, Ltd.20231—
+4K222988neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D CervicalHt Medical D.B.A. Xenix Medical20232—
+4K230607SPICCA Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+4K222874CarboClear Cervical Cage System, CarboClear Cervical VBR SystemCarbofix Orthpedics, Ltd.20230—
+4K230026SqualeImplanet, S.A.20230—
+4K223153Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.20220—
+4K222903Tailored-H Cervical Stand Alone SystemBespoke Technologies, LLC20220—
+4K212450Keos Anterior Cervical Interbody Fusion Device SystemKeos20220—
+4K214010Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA202249—
+4K213115CHENA-C Spacer SystemKahtnu Surgical, Inc.20210—