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
+6K233694Meridian Interbody System; WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20248—
+6K231739Cervical Spine Truss System (CSTS)4Web Medical, Inc.20232—
+6K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+6K230894NuVasive Modulus ALIF SystemNu Vasive, Incorporated20234—
+6K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+6K220261NEST-C Interbody SystemPaonan Biotech Co., Ltd.20230—
+6K223326Axiom PSR SystemRestor3D202301
+6K230583Tryptik TiSpineart SA20231—
+6K223146EVOLUTION SPINE Interbody SystemEvolution Spine20239—
+6K222554EL CAPITAN Anterior Lumbar Interbody FusionAstura Medical20235—
+6K221182Southern Transforaminal Lumbar Interbody Fusion (TLIF)Southern Medical (Pty), Ltd.20220—
+6K222009aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.202212—
+6K220334MONET Anterior Cervical Plate SystemCtl Medical Corporation20220—
+6K222732WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20229—
+6K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+6K221936Standalone ALIF Interbody Fusion SystemEminent Spine20222—
+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—
+6K220953ChoiceSpine TigerShark™ M, Modular Interbody SystemChoice Spine, LLC20220—
+6K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+6K222082aprevo® anterior and lateral lumbar interbody fusion devices, aprevo® transforaminal…Carlsmed, Inc.202211—
+6K220581Zavation eZspand Interbody SystemZavation Medical Products, LLC20224—
+6K220115ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion SystemMiRus, LLC20220—
+6K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+6K214047EL CAPITAN Anterior Lumbar Interbody Fusion SystemAstura Medical20223—
+6K220096Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20220—
+6K212266FIX-C PEEK Anterior Cervical Interbody SystemJeil Medical Corporation20217—
+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—
+6K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+6K210800IO Expandable Lumbar Interbody Fusion SystemMiRus, LLC20212—
+6K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+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—
+6K200458Tailored-C Cervical Interbody Fusion SystemBespoke Technologies20203—
+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—
+6K192208CORNICE Cervical Spacer SystemLegend Spine Technologies20190—
+6K191243HEDRON Cervical SpacersGlobus Medical, Inc.201936—
+6K192054Endoskeleton TAS PlateTitan Spine, Inc.20190—
+6K190885Elevation Spine Saber-C SystemElevation Spine201925—
+6K191565Endoskeleton TCS Interbody Fusion DeviceTitan Spine, Inc.201901
+6K183249Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved…Stryker Spine20196—
+6K191263Idys ALIF TiVacClariance, Sas20190—
+6K190877Juliet® Ti LL Lumbar Interbody DeviceSpineart201911
+6K182877HALF DOME Posterior Lumbar Interbody SystemAstura Medical, LLC201921—
+6K173518Spectrum Spine Expandable Cages (SSEC)Spectrum Spine, LLC20196—
+6K183397ChoiceSpine Stealth Cervical Spacer SystemChoicespine, LP201916—
+6K182885Atlantis™ Anterior Cervical Plate, Divergence™ Anterior Cervical Fusion System, Premier™…Medtronic Sofamor Danek USA, Inc.20198—
+6K190067Velofix Interbody Fusion SystemU&I Corporation20193—
+6K181096Avenue P Cage SystemZimmer Biomet Spine, Inc.20190—
+6K181118Reliance Lumbar IBF SystemReliance Medical Systems20190—
+6K180909REVEL SpacersGlobus Medical, Inc.201837—
+6K180550NuVasive Monolith Cervical Corpectomy SystemNu Vasive, Incorporated201811—
+6K181140Axis Chena Cervical PEEK Spacer SystemAxis Orthopaedics20182—
+6K181829Velofix TLIF CageU&I Corporation20181—
+6K181531SpineEX Sagittae Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20183—
+6K181397DualXInnovasive, Inc.201815—
+6K181328T2 STRATOSPHERE™ Expandable Corpectomy SystemMedtronic Sofamor Danek USA, Inc.201828—
+6K181229TirboLOX-C Cervical IBFDCaptiva Spine, Inc.20180—
+6K180695FBC 921 (Alif)Fbc Device Aps20180—
+6K180590Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20186—
+6K180364HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC2018106—
+6K173787X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage System…Medos International SARL20182—
+6K173722PATRIOT COLONIAL Spacer, SUSTAIN SpacerGlobus Medical, Inc.201894—
+6K180519HARRIER-SA™ Lumbar Interbody SystemChoicespine, LP20180—
+6K180002Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20182—
+6K180851VERTEX™ Reconstruction SystemMedtronic Sofamor Danek USA, Inc.20188—
+6K173082Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20185—
+6K172320Neurostructures Cavetto® Cervical Cage SystemNeurostructures, Inc.20183—
+6K172926SeaSpine Vu cPOD, Zuma-C, Complete CervicalSeaSpine Orthopedics Corporation201761—
+6K172185Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20177—
+6K173115COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and…Globus Medical, Inc.201783—
+6K172019Brisbane ALIF Device, Gladstone ALIF DeviceSignature Orthopaedics Pty, Ltd.20170—