510(k) Report

Devices descending from K040536

1,150 later devices reach Modification to Verte-Stack Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K131671MectalifMedacta International201322—
+1K120024Mectalif TransforaminalMedacta International S.A.201223—
+1K110927MectalifMedacta International2011301
+1K081383Reliance VBS SystemReliance Medical Systems, LLC20080—
+1K063637Reliance VBS SystemReliance Medical Systems, LLC20071—
+1K052261Modification to: Verte-Stack Spinal SystemMedtronic Sofamor Danek USA, Inc.2005839—
+1K041556Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek20041,002—
+2K251016MectaLIF 3D MetalMedacta International S.A.20250—
+2K212831MectaLIF ExtensionMedacta International S.A.20211—
+2K200551MectaLIF Transforaminal TiPEEKMedacta Inernational SA20214—
+2K192026Peridot Intervertebral body fusion SystemGbs Commonwealth Co., Ltd.20196—
+2K181970MectaLIF Posterior ExtensionMedacta International S.A.20182—
+2K133192Mectalif TipeekMedacta International201416—
+2K124034Mectalif AnteriorMedacta International201311—
+2K112862Mecta-CMedacta International201114—
+2K094025Crescent Spinal SystemMedtronic Sofamor Danek2010838—
+2K062133Modification to Verte-Stack Spinal SystemMedtronic Spinal and Biologics Div2006649—
+2K060719Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2006992—
+2K043561Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2004999—
+3K254202MectaLIF 3D Metal AnteriorMedacta International S.A.20260—
+3K241992Catalyft™ LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.20240—
+3K230708Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system); Anterior…Gbs Commonwealth Co., Ltd.20233—
+3K223153Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.20220—
+3K221545MectaLIF Anterior ExtensionMedacta International S.A.202226
+3K214010Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA202249—
+3K213980Peridot Spinal Interbody SystemGbs Commonwealth Co., Ltd.20224—
+3K210425Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.2021561
+3K202872Prase PEEK Anterior Cervical Interbody SpacerGbs Commonwealth Co., Ltd.20215—
+3K201267Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek202079—
+3K191788CAPSTONE Spinal System, CLYDESDALE PTC Spinal System, CRESCENT Spinal System, CRESCENT…Medtronic Sofamor Danek USA, Inc.20200—
+3K200048MectaLIF Anterior SimpleMedacta International S.A.20200—
+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—
+3K171689ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2017109—
+3K172199ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT…Medtronic Sofamor Danek20176—
+3K163422Shanghai Sanyou PEEK Cage SystemShanghai Sanyou Medical Co, Ltd.20173—
+3K172587Mecta-C with titanium markers and Mecta-C TiPEEK with titanium markersMedacta International S.A.20170—
+3K171031CRESCENT™ Spinal SystemMedtronic Sofamor Danek2017144—
+3K160605MectaLIF Anterior Stand-AloneMedacta International201610—
+3K150847Foundation Interbody DevicesCorelink, LLC201529—
+3K142559ELEVATE Spinal SystemMedtronic Sofamor Danek USA, Inc.2015130—
+3K142744Mecta-C TiPEEKMedacta International201512—
+3K132483Innesis Peek Cervical CageBk Meditech, Co., Ltd.20140—
+3K133893Sterispine LC CageSafe Orthopaedics20141—
+3K133216Crescent Spinal SystemMedtronic Sofamor Danek, Inc.201392—
+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—
+3K120368Capstone Control Spinal SystemMedtronic Sofamor Danek USA, Inc.2012761—
+3K110562Telamon Peek Spinal SystemMedtronic Sofamor Danek USA2011306—
+3K110543Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc.2011808—
+3K082342Modification to Capstone Spinal SystemMedtronic Sofamor Danek2008716—
+3K070173Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc.2007648—
+3K063491T2 Sceptor Spinal SystemMedtronic Sofamor Danek200753—
+3K062073Verte-Stack Spinal SystemMedtronic Sofamor Danek2006844—
+3K061938Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc.2006152—
+4K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+4K260810Anteralign LS coverplateTyber Medical, LLC20260—
+4K254017SWINGO-3D Lumbar Cage SystemImplanet20260—
+4K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+4K250669Adaptix™ Interbody System with Titan nanoLOCK™ Surface TechnologyMedtronic Sofamor Danek USA, Inc.20250—
+4K250603AxTiHA® Stand-Alone ALIF SystemInnovasis20250—
+4K241164IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic)202412
+4K241605Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spinal System…Nanovis, LLC20240—
+4K230872Halis™ Lumbar Cage System, Lydia™ Anterior Lumbar Fusion System, Dica™ Direction…Shanghai Sanyou Medical Co, Ltd.20231—
+4K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+4K232345ATEC Posterior Navigated Disc Prep InstrumentsAlphatec Spine, Inc.20232—
+4K232123MectaLIF Anterior Lag ExtensionMedacta International S.A.20231—
+4K232822Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system), Anterior…Gbs Commonwealth Co., Ltd.20232—
+4K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+4K223494CD Horizon Spinal SystemMedtronic202317—
+4K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+4K214011Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal…Medtronic Sofamor Danek USA, Inc.20221—
+4K212524Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.202155—
+4K211689KEYSTONE PEEK Cage SystemShanghai Sanyou Medical Co, Ltd.20212—
+4K201193SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202018—
+4K203076Mecta-C Stand Alone ExtensionMedacta International S.A.20200—
+4K191796Neo Cage SystemNeo Medical SA20190—
+4K192214CarboClear VBR SystemCarboFix Orthopedics, Ltd.20191—
+4K190959ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2019108—
+4K190165Capstone Control™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20196—
+4K183426MectaLIF Anterior Stand Alone ExtensionMedacta International S.A.20191—
+4K181048Neo Cage System TMNeo Medical SA20191—
+4K183239CoreLink F3D™ Lateral SystemCorelink, LLC20188—
+4K181357PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc.201897—
+4K180814CoreLink® M3™ Stand-Alone Anterior Lumbar SystemCorelink, LLC201818—
+4K180556Corelink Foundation 3D Anterior Lumbar SystemCorelink, LLC20185—
+4K172105The Plateau-LO Spacer SystemLife Spine, Inc.20181—
+4K170389TAURUS PEEK Cage SystemMedyssey USA, Inc.20170—
+4K163595IMPIX 3D Print CagesMedicrea International SA2017282
+4K172328SOVEREIGN™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201730—
+4K171107CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal SystemMedtronic Sofamor Danek USA, Inc.20178—
+4K171468FUSE Spinal SystemMedtronic Sofamor Danek20170—
+4K163581Navigated ELEVATE Inserter, Navigated Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.2017103—
+4K170455MectaLIF Anterior Stand AloneMedacta International S.A.20174—
+4K161404Genesys Spine Apache® Lateral Lumbar Interbody Fusion SystemGenesys Spine201610—
+4K153621Juliet® TiSpineart2016751
+4K151665SUSTAIN Additional ImplantsGlobus Medical, Inc.2016119—
+4K152355Twin Peaks Lumbar Interbody Fusion SystemSpineway20151—
+4K151538NuVasive PEEK Corpectomy Railed SystemNu Vasive, Incorporated201513—
+4K151167NuVasive PEEK Corpectomy SystemNu Vasive, Incorporated201513—