510(k) Report

Devices descending from K052261

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+5K233947KLIMT™ Expandable Lumbar Interbody Fusion (LIF) Cage SystemCtl Medical Corporation20240—
+5K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+5K241846E3D™-C Interbody SystemEvolution Spine20246—
+5K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+5K241321Juliet® Ti LL Lumbar Interbody DeviceSpineart SA20240—
+5K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc.20242—
+5K241466Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System…SeaSpine Orthopedics Corporation20243—
+5K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+5K240699SCARLET® AC-TiSpineart SA20240—
+5K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+5K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+5K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+5K234087restor3d TIDAL Lumbar Interbody Fusion SystemRestor3D20240—
+5K233694Meridian Interbody System; WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20248—
+5K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+5K230894NuVasive Modulus ALIF SystemNu Vasive, Incorporated20234—
+5K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+5K220261NEST-C Interbody SystemPaonan Biotech Co., Ltd.20230—
+5K223326Axiom PSR SystemRestor3D202301
+5K230583Tryptik TiSpineart SA20231—
+5K223146EVOLUTION SPINE Interbody SystemEvolution Spine20239—
+5K222554EL CAPITAN Anterior Lumbar Interbody FusionAstura Medical20235—
+5K221182Southern Transforaminal Lumbar Interbody Fusion (TLIF)Southern Medical (Pty), Ltd.20220—
+5K222009aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.202212—
+5K222732WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20229—
+5K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+5K221936Standalone ALIF Interbody Fusion SystemEminent Spine20222—
+5K221646CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™…Medtronic Sofamor Danek USA, Inc.202220—
+5K213417Ghost Spacer SystemLife Spine, Inc.20220—
+5K220953ChoiceSpine TigerShark™ M, Modular Interbody SystemChoice Spine, LLC20220—
+5K222082aprevo® anterior and lateral lumbar interbody fusion devices, aprevo® transforaminal…Carlsmed, Inc.202211—
+5K220581Zavation eZspand Interbody SystemZavation Medical Products, LLC20224—
+5K220115ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion SystemMiRus, LLC20220—
+5K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+5K214047EL CAPITAN Anterior Lumbar Interbody Fusion SystemAstura Medical20223—
+5K220096Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20220—
+5K212075ShurFit Lumbar Interbody SystemPrecision Spine, Inc.20211—
+5K210470C-CURVE Interbody Fusion DeviceMedicrea International SA20210—
+5K212070KMTI S141 Lumbar Interbody Fusion SystemKyocera Medical Technologies, Inc.20210—
+5K210090Impulse AM Interbody Fusion SystemDegen Medical20217—
+5K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+5K210800IO Expandable Lumbar Interbody Fusion SystemMiRus, LLC20212—
+5K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+5K210542aprevo Transforaminal IBFCarlsmed, Inc.202112—
+5K210595SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar SpacersCamber Spine Technologies, LLC20213—
+5K211258Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA…Medtronic Sofamor Danek USA, Inc.202175—
+5K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemNu Vasive, Incorporated20213—
+5K201671A-Link ZAcuity Surgical Devices, LLC202125—
+5K200919Idys ALIF 3DTiClariance20210—
+5K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+5K202032Idys LLIF 3DTiClariance, Sas20210—
+5K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135—
+5K203683CarboClear Lumbar Cage SystemCarbofix Orthpedics, Ltd.20211—
+5K202495SIRION Lateral Lumbar Interbody FusionAstura Medical, LLC20216—
+5K202820Australis Anterior Lumbar Cage SystemPrism Surgical Designs Pty, Ltd.20200—
+5K202034aprevo Intervertebral Body Fusion DeviceCarlsmed, Inc.202017—
+5K200316UNiD IB3D ALIFMedicrea International SA20200—
+5K201585Monterey AL Interbody SystemStryker Corporation202044
+5K201087CORBEL SpacersGlobus Medical, Inc.202036—
+5K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+5K200920Idys ALIF ZP 3DTiClariance, Sas20203—
+5K200991EVOL Spinal Interbody SystemCutting Edge Spine, LLC20200—
+5K192006SIRION Lateral Lumbar Interbody SystemAstura Medical, LLC202014—
+5K193378CarboClear Lumbar Cage SystemCarboFix Orthopedics, Ltd.20202—
+5K192993Scarlet AL-TSpineart20201—
+5K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine20207—
+5K191581Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion…Titan Spine, Inc.202081—
+5K192497EVOL ha - D Lateral Interbody Fusion SystemCutting Edge Spine, LLC20201—
+5K193174Keos Lumbar IBFDKeos20190—
+5K192336Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.201917—
+5K192168Idys ALIF ZP 3DTiClariance, Sas20195—
+5K192054Endoskeleton TAS PlateTitan Spine, Inc.20190—
+5K183249Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved…Stryker Spine20196—
+5K191263Idys ALIF TiVacClariance, Sas20190—
+5K190877Juliet® Ti LL Lumbar Interbody DeviceSpineart201911
+5K182877HALF DOME Posterior Lumbar Interbody SystemAstura Medical, LLC201921—
+5K173518Spectrum Spine Expandable Cages (SSEC)Spectrum Spine, LLC20196—
+5K183397ChoiceSpine Stealth Cervical Spacer SystemChoicespine, LP201916—
+5K181096Avenue P Cage SystemZimmer Biomet Spine, Inc.20190—
+5K181118Reliance Lumbar IBF SystemReliance Medical Systems20190—
+5K181531SpineEX Sagittae Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20183—
+5K181397DualXInnovasive, Inc.201815—
+5K180695FBC 921 (Alif)Fbc Device Aps20180—
+5K180590Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20186—
+5K173787X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage System…Medos International SARL20182—
+5K180519HARRIER-SA™ Lumbar Interbody SystemChoicespine, LP20180—
+5K180002Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20182—
+5K173082Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20185—
+5K170235Lucent®Spinal Elements, Inc.2017107—
+5K172392Lateral Spinal Truss System (LSTS) Interbody Fusion Device4Web, Inc.20171—
+5K171914Cortina™ Lumbar Cage SystemNeurostructures, Inc.20172—
+5K171630LumFuse-TPPrecifit Medical, Ltd.20171—
+5K170318NeoFuse Ti3D PLIF/TLIF/Cervical InterbodyHt Medical, LLC201749—
+5K162358T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution SystemSynthes USA Products, LLC2016127—
+5K161379ELSA SpacersGlobus Medical, Inc.2016155—
+5K161173Avenue® T TLIF CageLdr Spine USA, Inc.20163—
+5K161888JULIET® LL Lateral Lumbar CageSpineart2016145—
+5K161230NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated2016381—
+5K153495Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T…Ldr Spine USA20161891