510(k) Report

Devices descending from K030601

1,151 later devices reach Verte-Stack Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K210542aprevo Transforaminal IBFCarlsmed, Inc.202112—
+6K210595SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar SpacersCamber Spine Technologies, LLC20213—
+6K211258Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA…Medtronic Sofamor Danek USA, Inc.202175—
+6K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemNu Vasive, Incorporated20213—
+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—
+6K203683CarboClear Lumbar Cage SystemCarbofix Orthpedics, Ltd.20211—
+6K202495SIRION Lateral Lumbar Interbody FusionAstura Medical, LLC20216—
+6K202820Australis Anterior Lumbar Cage SystemPrism Surgical Designs Pty, Ltd.20200—
+6K202034aprevo Intervertebral Body Fusion DeviceCarlsmed, Inc.202017—
+6K200316UNiD IB3D ALIFMedicrea International SA20200—
+6K201585Monterey AL Interbody SystemStryker Corporation202044
+6K201087CORBEL SpacersGlobus Medical, Inc.202036—
+6K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+6K200920Idys ALIF ZP 3DTiClariance, Sas20203—
+6K200991EVOL Spinal Interbody SystemCutting Edge Spine, LLC20200—
+6K192006SIRION Lateral Lumbar Interbody SystemAstura Medical, LLC202014—
+6K193378CarboClear Lumbar Cage SystemCarboFix Orthopedics, Ltd.20202—
+6K192993Scarlet AL-TSpineart20201—
+6K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine20207—
+6K191581Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion…Titan Spine, Inc.202081—
+6K192497EVOL ha - D Lateral Interbody Fusion SystemCutting Edge Spine, LLC20201—
+6K193174Keos Lumbar IBFDKeos20190—
+6K192336Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.201917—
+6K192168Idys ALIF ZP 3DTiClariance, Sas20195—
+6K192054Endoskeleton TAS PlateTitan Spine, Inc.20190—
+6K183249Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved…Stryker Spine20196—
+6K183243Velofix TLIF CageU&I Corporation20190—
+6K191263Idys ALIF TiVacClariance, Sas20190—
+6K190877Juliet® Ti LL Lumbar Interbody DeviceSpineart201911
+6K182877HALF DOME Posterior Lumbar Interbody SystemAstura Medical, LLC201921—
+6K183197PYRAMESH™ Implant SystemMedtronic Sofamor Danek USA, Inc.20190—
+6K173518Spectrum Spine Expandable Cages (SSEC)Spectrum Spine, LLC20196—
+6K183397ChoiceSpine Stealth Cervical Spacer SystemChoicespine, LP201916—
+6K183510T2 STRATOSPHERE Expandable Corpectomy SystemMedtronic Sofamor Danek USA, Inc.201927—
+6K181096Avenue P Cage SystemZimmer Biomet Spine, Inc.20190—
+6K181118Reliance Lumbar IBF SystemReliance Medical Systems20190—
+6K181531SpineEX Sagittae Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20183—
+6K181397DualXInnovasive, Inc.201815—
+6K180695FBC 921 (Alif)Fbc Device Aps20180—
+6K180590Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20186—
+6K173787X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage System…Medos International SARL20182—
+6K180519HARRIER-SA™ Lumbar Interbody SystemChoicespine, LP20180—
+6K172568CervagePrecifit Medical, Ltd.20181—
+6K180002Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20182—
+6K173082Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20185—
+6K173125T2 STRATOSPHERE™ Expandable Corpectomy SystemMedtronic Sofamor Danek201747—
+6K172419Velofix™ TLIF CageU&I Corporation20172—
+6K170235Lucent®Spinal Elements, Inc.2017107—
+6K172392Lateral Spinal Truss System (LSTS) Interbody Fusion Device4Web, Inc.20171—
+6K171914Cortina™ Lumbar Cage SystemNeurostructures, Inc.20172—
+6K171630LumFuse-TPPrecifit Medical, Ltd.20171—
+6K171749Velofix (tm) Interbody Fusion SystemU&I Corporation20175—
+6K170318NeoFuse Ti3D PLIF/TLIF/Cervical InterbodyHt Medical, LLC201749—
+6K170271NuVasive (r) Monolith Corpectomy SystemNu Vasive, Incorporated201712—
+6K162531Sterispine CCSafe Orthopaedics20160—
+6K162358T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution SystemSynthes USA Products, LLC2016127—
+6K161379ELSA SpacersGlobus Medical, Inc.2016155—
+6K161173Avenue® T TLIF CageLdr Spine USA, Inc.20163—
+6K161888JULIET® LL Lateral Lumbar CageSpineart2016145—
+6K161230NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated2016381—
+6K153495Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T…Ldr Spine USA20161891
+6K153400ProLift Expandable SystemLife Spine, Inc.201672—
+6K151726AVS AL and AVS ALign PEEK Spacers, AVS PL and AVS UniLIF PEEK Spacers, AVS TL PEEK…Stryker Corporation20161391
+6K153373CORNERSTONE PSR Cervical Fusion System, PERIMETER C Spinal System, PEEK PREVAIL Cervical…Medtronic Sofamor Danek2016110—
+6K152651AccuLIF TL and PL CageStryker Corporation201530—
+6K152304Tritanium PL CageStryker20154481
+6K151472NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated2015479—
+6K142218Coalition AGX Plate and Coalition AGX SpacerGlobus Medical, Inc.2015155—
+6K142940Endoskeleton TCS SystemTitan Spine, LLC20151112
+6K142066Aero-LL Lumbar Cage SystemStryker Corporation20142—
+6K133813Flxfit Intervertebral Body Fusion DeviceExpanding Orthopedics, Inc.2014137—
+6K140417Divergence Mini-Plate Anterior Cervical Fusion SystemMedtronic Sofamor Danek, Inc.201411—
+6K133494Chesapeake Spinal SystemK2m, Inc.2014330—
+6K123607Octane Elevate Spinal Implant SystemExactech, Inc.20141—
+6K132584Perimeter C Spinal SystemMedtronic Sofamor Danek USA, Inc.2013119—
+6K131888T2 XVBR Spinal System, T2 Altitude Expandable Corpectomy DeviceMedtronic Sofamor Danek, Inc.20130—
+6K132505Acculif TL and PL CageCoalign Innovations, Inc.20136453
+6K131443Coalign Innovations Acculif XL Ibf CageCoalign Innovations, Inc.20130—
+6K130194Acculif XL CageCoalign Innovations, Inc.20131—
+6K120275Synthes Acis/Vertebral Spacer CRSynthes (Usa), LLC2012173—
+6K112459Synthes Zero-PSynthes Spine Co.Lp2011277—
+6K112068Synthes Zero-P Variable Angle (VA)Synthes Spine Co.Lp2011331
+6K100967Perimeter C Spinal SystemMedtronic Sofamor Danek USA, Inc.2011121—
+6K102323Cervical Standalone Intervertebral Body Fusion DeviceTheken Spine, LLC201062—
+6K100976T2 XVBR 1.5 Spinal SystemMedtronic Sofamor Danek USA, Inc.201049—
+6K094042Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek2010397—
+6K100214Cornerstone PSR Cervical Interbody Fusion DeviceMedtronic Sofamor Danek2010389—
+6K070742Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek2007150—
+7K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—
+7K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+7K262094E3D™-C Interbody SystemEvolution Spine20260—
+7K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+7K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+7K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+7K253151Fule Interbody Fusion Cage SystemBeijing Fule Science & Technology Development Co., Ltd.20260—
+7K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—