510(k) Report

Devices descending from K030736

1,101 later devices reach Verte-Stack Spinal System, Extra Small Sizes through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K111294Santorini Spinal SystemK2m, Inc.201218—
+1K081383Reliance VBS SystemReliance Medical Systems, LLC20080—
+1K063637Reliance VBS SystemReliance Medical Systems, LLC20071—
+1K061938Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc.2006152—
+1K060719Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2006992—
+1K052931Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2005993—
+1K041197Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2004994—
+1K033926Hourglass Vertebral Body SpacerMedtronic Sofamor Danek2004763—
+1K041452Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2004815—
+2K183197PYRAMESH™ Implant SystemMedtronic Sofamor Danek USA, Inc.20190—
+2K173125T2 STRATOSPHERE™ Expandable Corpectomy SystemMedtronic Sofamor Danek201747—
+2K171704CAPRI Corpectomy Cage SystemK2m201710—
+2K162133VerteFIT Corpectomy Cage SystemLdr Spine USA, Inc.20170—
+2K170055CAPRI Corpectomy Cage SystemK2m201711—
+2K151481Sahara Stabilization SystemK2m, Inc.20155—
+2K142016CAPRIK2m, Inc.201412—
+2K123758Tasmin RSignus Medizintechnik GmbH20141—
+2K120368Capstone Control Spinal SystemMedtronic Sofamor Danek USA, Inc.2012761—
+2K111264Cornerstone (R) PSR Cervical Fusion SystemMedtronic Sofamor Danek USA2011331—
+2K100214Cornerstone PSR Cervical Interbody Fusion DeviceMedtronic Sofamor Danek2010389—
+2K090353Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek2009796—
+2K071033T2 XVBR Spinal SystemMedtronic Sofamor Danek200750—
+2K070173Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc.2007648—
+2K063491T2 Sceptor Spinal SystemMedtronic Sofamor Danek200753—
+2K062133Modification to Verte-Stack Spinal SystemMedtronic Spinal and Biologics Div2006649—
+2K062427Verte-Stack Spinal SystemMedtronic Sofamor Danek2006151—
+2K062073Verte-Stack Spinal SystemMedtronic Sofamor Danek2006844—
+2K051105Basis Vertebral Body SpacerMedtronic Sofamor Danek20050—
+2K043566Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2005726—
+3K242303MOD-COrthomod, LLC20260—
+3K241438Signus Tetris™ St; Signus Tetris™ R StSignus Medizintechnik GmbH20240—
+3K201585Monterey AL Interbody SystemStryker Corporation202044
+3K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+3K192214CarboClear VBR SystemCarboFix Orthopedics, Ltd.20191—
+3K191039Navigated T2 STRATOSPHERE Inserters and Navigated TemplatesMedtronic Sofamor Danek USA, Inc.201918—
+3K190165Capstone Control™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20196—
+3K183510T2 STRATOSPHERE Expandable Corpectomy SystemMedtronic Sofamor Danek USA, Inc.201927—
+3K180665SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage SystemK2m, LLC20189—
+3K181328T2 STRATOSPHERE™ Expandable Corpectomy SystemMedtronic Sofamor Danek USA, Inc.201828—
+3K172105The Plateau-LO Spacer SystemLife Spine, Inc.20181—
+3K163366Shanghai Sanyou CARMEN Cervical Fusion SystemShanghai Sanyou Medical Co, Ltd.20170—
+3K171107CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal SystemMedtronic Sofamor Danek USA, Inc.20178—
+3K171468FUSE Spinal SystemMedtronic Sofamor Danek20170—
+3K161404Genesys Spine Apache® Lateral Lumbar Interbody Fusion SystemGenesys Spine201610—
+3K153621Juliet® TiSpineart2016751
+3K153123Genesys Spine Apache Interbody Fusion SystemGenesys Spine201612—
+3K151665SUSTAIN Additional ImplantsGlobus Medical, Inc.2016119—
+3K160418PERIMETER Interbody Fusion DeviceMedtronic Sofamor Danek USA, Inc.20165—
+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—
+3K150321EVOS Lumbar Interbody SystemCutting Edge Spine, LLC201592—
+3K150135DIVERGENCE-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc.2015228—
+3K141599Divergence Anterior Cervical Fusion SystemMedtronic Sofamor Danek USA, Inc.201516—
+3K142277Juliet POSpineart2014119—
+3K140417Divergence Mini-Plate Anterior Cervical Fusion SystemMedtronic Sofamor Danek, Inc.201411—
+3K140474Juliet OLSpineart2014120—
+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—
+3K132897Clydesdale Spinal SystemMedtronic Sofamor Danek, Inc.2013279—
+3K132584Perimeter C Spinal SystemMedtronic Sofamor Danek USA, Inc.2013119—
+3K130853Idys (TM) CClariance20132—
+3K132700Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek, Inc.2013170—
+3K131296Varilift-L Interbody Fusion DeviceWenzel Spine, 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—
+3K121760Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2012723—
+3K121982Sovereign Spinal SystemMedtronic Sofamor Danek2012155—
+3K120275Synthes Acis/Vertebral Spacer CRSynthes (Usa), LLC2012173—
+3K113642Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek USA2012292—
+3K113528Clydesdale (R) Spinal SystemMedtronic Sofamor Danek USA, Inc.2011361—
+3K112444Anatomic Peek Cervical Fusion SystemMedtronic Sofamor Danck USA, Inc.2011324—
+3K110442Nanovis Intervertebral Body Fusion SystemNanovis, LLC201110—
+3K111525Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek2011355—
+3K100967Perimeter C Spinal SystemMedtronic Sofamor Danek USA, Inc.2011121—
+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—
+3K082342Modification to Capstone Spinal SystemMedtronic Sofamor Danek2008716—
+3K073285Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek USA, Inc.2008637—
+3K070742Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek2007150—
+3K052670Staxx XD SystemSpine Wave, Inc.20068—
+4K261049Scala® TLSpineart SA20260—
+4K261408SABER-XA SystemElevation Spine20260—
+4K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc.20251—
+4K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+4K242195Gemini Cervical Fusion Cage SystemZheJiang Decans Medical Devices Co., Ltd.20241—
+4K241992Catalyft™ LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.20240—
+4K242267Gemini Medical Cage SystemZheJiang Decans Medical Devices Co., Ltd.20241—
+4K241164IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic)202412
+4K241605Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spinal System…Nanovis, LLC20240—
+4K231739Cervical Spine Truss System (CSTS)4Web Medical, Inc.20232—
+4K222874CarboClear Cervical Cage System, CarboClear Cervical VBR SystemCarbofix Orthpedics, Ltd.20230—
+4K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+4K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+4K223153Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.20220—
+4K214010Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA202249—
+4K211320CAPRI Corpectomy Cage SystemK2m, Inc.20222—
+4K212358Romero Cervical CageSpineup, Inc.20226—
+4K212266FIX-C PEEK Anterior Cervical Interbody SystemJeil Medical Corporation20217—