510(k) Report

Devices descending from K030735

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K191066CD Horizon™ Astute™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201921—
+5K190708AccelFix Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20195—
+5K183243Velofix TLIF CageU&I Corporation20190—
+5K182920MiRus™ Lumbar Interbody Fusion System consisting of CALLISTO™ PEEK Posterior Lumbar…MiRus, LLC20199—
+5K180230NEST Interbody SystemPaonan Biotech Co., Ltd.20191—
+5K181899Roccia® PlifSilony Medical GmbH20180—
+5K181357PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc.201897—
+5K182470Plateau Spacer SystemLife Spine20180—
+5K181818Scarlet AL-TSpineart201864—
+5K181203Juliet TiSpineart20181—
+5K180674EVOL® ha-C Cervical Interbody Fusion SystemCutting Edge Spine, LLC20183—
+5K173189Lumfuse TPPrecifit Medical, Ltd.20180—
+5K180891EVOL Spinal Interbody System, EVOS Lumbar Interbody SystemCutting Edge Spine, LLC20181—
+5K180071STYLO Interbody Fusion DeviceLegend Spine Technologies20180—
+5K172947HALF DOME Posterior Lumbar Interbody SystemAstura Medical201822—
+5K172816TiGer Shark™ SystemChoicespine, LP201859—
+5K173702Juliet Ti LLSpineart20182—
+5K171848FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO…Globus Medical, Inc.201755—
+5K172349InFill® Interbody Fusion DevicePinnacle Spine Group, LLC20171—
+5K172419Velofix™ TLIF CageU&I Corporation20172—
+5K163595IMPIX 3D Print CagesMedicrea International SA2017282
+5K172083Idys™ ALIF SystemClariance, Sas20177—
+5K172392Lateral Spinal Truss System (LSTS) Interbody Fusion Device4Web, Inc.20171—
+5K171689ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2017109—
+5K172199ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT…Medtronic Sofamor Danek20176—
+5K171657ShurFit 2C Lumbar Interbody Fusion SystemPrecision Spine, Inc.20174—
+5K170851Anterior Spine Truss System (STS) Interbody Fusion Device4Web, Inc.20175—
+5K171749Velofix (tm) Interbody Fusion SystemU&I Corporation20175—
+5K162212Divergence-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc.201757—
+5K163670Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20173—
+5K162680SOVEREIGN® Spinal SystemMedtronic Sofamor Danek USA, Inc.201631—
+5K162327COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL2016111—
+5K160924Amendia Interbody Fusion DevicesAmendia, Inc.2016166—
+5K160631Keos Lumbar IBFDKeos20161—
+5K153615NeoFuse HA Enhanced PLIF/TLIFHt Medical, LLC201650—
+5K151773CONCORDE Bullet Lumbar Interbody SystemMedos International SARL2015201—
+5K152277PIVOX (tm) Oblique Lateral Spinal SystemMedtronic Sofamor Danek USA, Inc.2015190—
+5K150673SYNFIX Evolution Secured Spacer SystemSynthes (USA) Products, LLC2015137—
+5K151140LnK Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.201529—
+5K151128CAPSTONE Spinal System, CLYDESDALE Spinal SystemMedtronic Sofamor Danek USA, Inc.2015255—
+5K142645Avenue T TLIF CageLdr Spine USA, Inc.2015191—
+5K142559ELEVATE Spinal SystemMedtronic Sofamor Danek USA, Inc.2015130—
+5K143616AccuLIF TL and PL CageStryker Corporation20154694
+5K141896Coroent SystemNu Vasive, Incorporated2014480—
+5K142101Abacus (TM) Spacer SystemSpine Wave, Inc.20140—
+5K133577Clydesdale (R) Spinal SystemMedtronic Sofamor Danek USA, Inc.2014256—
+5K140709Skyhawk Interbody Fusion SystemOrthofix, Inc.20147—
+5K133557Juliet LL Lateral Lumbar CageSpineart2014147—
+5K131276Lateral SynfixSynthes (USA) Products, LLC2014146—
+5K133207Staxx (R) SystemSpine Wave, Inc.20131—
+5K101288Staxx XD SystemSpine Wave, Inc.201051
+6K260810Anteralign LS coverplateTyber Medical, LLC20260—
+6K252610ZSFab Lumbar Interbody SystemZsfab, Inc.20251—
+6K252742Navigated InstrumentsTyber Medical, LLC20251—
+6K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc.20251—
+6K251741PathLoc Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20250—
+6K251459OneLIF™ Interbody Fusion SystemNovapproach Spine, LLC20250—
+6K250669Adaptix™ Interbody System with Titan nanoLOCK™ Surface TechnologyMedtronic Sofamor Danek USA, Inc.20250—
+6K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+6K250605EVOL® ha – Hyper C Cervical Interbody Fusion SystemCutting Edge Spine, LLC20250—
+6K242589Scarlet® AL-TSpineart SA20240—
+6K242829BluEX Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20240—
+6K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+6K241321Juliet® Ti LL Lumbar Interbody DeviceSpineart SA20240—
+6K240699SCARLET® AC-TiSpineart SA20240—
+6K234087restor3d TIDAL Lumbar Interbody Fusion SystemRestor3D20240—
+6K233594Genesys Spine 3DP AIS-C II Cervical Interbody SystemGenesys Spine20232—
+6K232345ATEC Posterior Navigated Disc Prep InstrumentsAlphatec Spine, Inc.20232—
+6K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+6K231680AccelFix Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20231—
+6K230607SPICCA Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+6K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+6K220513NITRO Interbody Fusion Cage System FamilyCtl Medical Corporation20230—
+6K220261NEST-C Interbody SystemPaonan Biotech Co., Ltd.20230—
+6K223326Axiom PSR SystemRestor3D202301
+6K230583Tryptik TiSpineart SA20231—
+6K223494CD Horizon Spinal SystemMedtronic202317—
+6K221182Southern Transforaminal Lumbar Interbody Fusion (TLIF)Southern Medical (Pty), Ltd.20220—
+6K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+6K221646CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™…Medtronic Sofamor Danek USA, Inc.202220—
+6K213417Ghost Spacer SystemLife Spine, Inc.20220—
+6K222383Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX Stealth (TM)…Medtronic Sofamor Danek USA, Inc.20220—
+6K213641MONDRIAN ALIF Cage with Supplementary Fixation PlateCtl Medical Corporation20221—
+6K220953ChoiceSpine TigerShark™ M, Modular Interbody SystemChoice Spine, LLC20220—
+6K213355Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20224—
+6K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+6K212075ShurFit Lumbar Interbody SystemPrecision Spine, Inc.20211—
+6K201793EDEN Peek CageJmt Co., Ltd.20210—
+6K212070KMTI S141 Lumbar Interbody Fusion SystemKyocera Medical Technologies, Inc.20210—
+6K210090Impulse AM Interbody Fusion SystemDegen Medical20217—
+6K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+6K211388Lateral Spine Truss System (LSTS) Interbody Fusion Device4Web Medical, Inc.20210—
+6K201671A-Link ZAcuity Surgical Devices, LLC202125—
+6K200919Idys ALIF 3DTiClariance20210—
+6K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+6K202032Idys LLIF 3DTiClariance, Sas20210—
+6K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135—
+6K203531XYPAN Expandable Lumbar Cage SystemAegis Spine, Inc.20213—
+6K203683CarboClear Lumbar Cage SystemCarbofix Orthpedics, Ltd.20211—
+6K202495SIRION Lateral Lumbar Interbody FusionAstura Medical, LLC20216—