510(k) Report

Devices descending from K030735

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K081383Reliance VBS SystemReliance Medical Systems, LLC20080—
+1K063637Reliance VBS SystemReliance Medical Systems, LLC20071—
+1K041452Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2004815—
+2K090353Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek2009796—
+2K043566Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2005726—
+3K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+3K190165Capstone Control™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20196—
+3K153123Genesys Spine Apache Interbody Fusion SystemGenesys Spine201612—
+3K160418PERIMETER Interbody Fusion DeviceMedtronic Sofamor Danek USA, Inc.20165—
+3K133645Perimeter C Spinal System, Capstone Spinal System, Capstone L Spinal System, Perimeter…Medtronic Sofamor Danek USA, Inc.20146—
+3K132897Clydesdale Spinal SystemMedtronic Sofamor Danek, Inc.2013279—
+3K132700Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek, Inc.2013170—
+3K131296Varilift-L Interbody Fusion DeviceWenzel Spine, Inc.20130—
+3K120368Capstone Control Spinal SystemMedtronic Sofamor Danek USA, Inc.2012761—
+3K113642Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek USA2012292—
+3K113528Clydesdale (R) Spinal SystemMedtronic Sofamor Danek USA, Inc.2011361—
+3K111525Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek2011355—
+3K082342Modification to Capstone Spinal SystemMedtronic Sofamor Danek2008716—
+3K052670Staxx XD SystemSpine Wave, Inc.20068—
+4K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+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—
+4K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+4K223153Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.20220—
+4K212524Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.202155—
+4K211689KEYSTONE PEEK Cage SystemShanghai Sanyou Medical Co, Ltd.20212—
+4K210425Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.2021561
+4K191788CAPSTONE Spinal System, CLYDESDALE PTC Spinal System, CRESCENT Spinal System, CRESCENT…Medtronic Sofamor Danek USA, Inc.20200—
+4K191796Neo Cage SystemNeo Medical SA20190—
+4K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20199—
+4K181048Neo Cage System TMNeo Medical SA20191—
+4K172105The Plateau-LO Spacer SystemLife Spine, Inc.20181—
+4K172328SOVEREIGN™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201730—
+4K171107CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal SystemMedtronic Sofamor Danek USA, Inc.20178—
+4K163422Shanghai Sanyou PEEK Cage SystemShanghai Sanyou Medical Co, Ltd.20173—
+4K171656Genesys Spine Apache Interbody Fusion SystemGenesys Spine20170—
+4K171031CRESCENT™ Spinal SystemMedtronic Sofamor Danek2017144—
+4K171468FUSE Spinal SystemMedtronic Sofamor Danek20170—
+4K161438Genesys Spine Apache® Anterior Lumbar Interbody Fusion SystemGenesys Spine201611—
+4K153665Prow Fusion-LNlt Spine, Ltd.20160—
+4K161404Genesys Spine Apache® Lateral Lumbar Interbody Fusion SystemGenesys Spine201610—
+4K153621Juliet® TiSpineart2016751
+4K153436LATERAL Spine Truss System4Web, Inc.20165—
+4K151665SUSTAIN Additional ImplantsGlobus Medical, Inc.2016119—
+4K153438PERIMETER C (Titanium) Spinal SystemMedtronic Sofamor Danek USA, Inc.20160—
+4K151310Amendia Interbody Fusion DevicesAmendia, Inc.2016169—
+4K150321EVOS Lumbar Interbody SystemCutting Edge Spine, LLC201592—
+4K150135DIVERGENCE-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc.2015228—
+4K142277Juliet POSpineart2014119—
+4K140563Lateral VBR SystemNu Vasive, Incorporated20140—
+4K140864Veloxtm Interbody Fusion SystemU&I Corp.20149—
+4K140474Juliet OLSpineart2014120—
+4K133205Capstone PTC Spinal System, Clydesdale PTC Spinal SystemMedtronic Sofamor Danek USA, Inc.2014124—
+4K132926Velofixtm Interbody Fusion SystemU&I Corp.201410—
+4K123758Tasmin RSignus Medizintechnik GmbH20141—
+4K133650Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2013344—
+4K131669Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek USA, Inc.2013234—
+4K123027Capstone (R) Spinal SystemMedtronic Sofamor Danek, Inc.2013709—
+4K123978Capstone L Spinal SystemMedtronic Sofamor Danek USA201313—
+4K122037Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion System Peek Prevail…Medtronic Sofamor Danek, Inc.2013281—
+4K122989Biomet Lateral Spacer SystemBiomet Spine (Aka Ebi, LLC)2012171—
+4K121567Oracle Lumbar Intervertebral Body Fusion Cage SystemAccel Spine20125—
+4K122591Clydesdale Spinal SystemMedtronic Sofamor Danek, Inc.201214—
+4K121760Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2012723—
+4K121982Sovereign Spinal SystemMedtronic Sofamor Danek2012155—
+4K121096Venus Lumbar Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd.201236—
+4K120063Venus Lumbar Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd.201237—
+4K102315Staxx XDL SystemSpine Wave, Inc.20113—
+4K111469Staxxsd SystemSpine Wave, Inc.20110—
+4K090315Staxx XD SystemSpine Wave, Inc.20096—
+4K082732Modification to: Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2008710—
+4K080860Creaspine Supstance Small Vertebral Body Replacement SystemCreaspine20080—
+5K261049Scala® TLSpineart SA20260—
+5K261408SABER-XA SystemElevation Spine20260—
+5K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+5K253213SAGI Cervical Cage SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+5K254017SWINGO-3D Lumbar Cage SystemImplanet20260—
+5K253577IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)Medicrea International S.A.S. (Medtronic)20250—
+5K252351UniSpace® TPLIF CageCg Medtech Co., Ltd.20250—
+5K241438Signus Tetris™ St; Signus Tetris™ R StSignus Medizintechnik GmbH20240—
+5K233375Tranquil-L Interbody SystemNexus Spine, LLC20240—
+5K230872Halis™ Lumbar Cage System, Lydia™ Anterior Lumbar Fusion System, Dica™ Direction…Shanghai Sanyou Medical Co, Ltd.20231—
+5K220523restor3d TiDAL Lumbar Interbody Fusion DeviceRestor3D20222—
+5K221180Anteralign (TM) Spinal System with Titan NanoLOCK Surface Technology Navigated InstrumentsMedtronic Sofamor Danek USA, Inc.20222—
+5K214010Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA202249—
+5K213441PathLoc Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20222—
+5K220096Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20220—
+5K214011Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal…Medtronic Sofamor Danek USA, Inc.20221—
+5K212653Catalyft LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.202127
+5K212389Advantage Lumbar System - ALIF, PLIF, DLIF, TLIFIntelivation, LLC20210—
+5K211769OneLIF Intervertebral Body Replacement SystemNovapproach Spine202112
+5K210044Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System…Spinal Elements, Inc.20211—
+5K203038Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20215—
+5K192863MONDRIAN Lumbar Interbody Fusion Cage SystemCtl Medical Corporation20203—
+5K201267Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek202079—
+5K200312Tryptik TiSpineart20202—
+5K200552EVOS Lumbar Interbody SystemCutting Edge Spine, LLC20200—
+5K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine20207—