510(k) Report

Devices descending from K043566

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+7K251459OneLIF™ Interbody Fusion SystemNovapproach Spine, LLC20250—
+7K243386Ventris Intervertebral Body Fusion DeviceAcuity Surgical Devices, LLC20252—
+7K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+7K250605EVOL® ha – Hyper C Cervical Interbody Fusion SystemCutting Edge Spine, LLC20250—
+7K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+7K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+7K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+7K242734ZSFab Cervical Interbody System; ZSFab Lumbar Interbody SystemZsfab20243—
+7K242589Scarlet® AL-TSpineart SA20240—
+7K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+7K242826ProLift Wedge Expandable Spacer SystemLife Spine, Inc.20240—
+7K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+7K241846E3D™-C Interbody SystemEvolution Spine20246—
+7K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+7K241321Juliet® Ti LL Lumbar Interbody DeviceSpineart SA20240—
+7K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc.20242—
+7K241466Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System…SeaSpine Orthopedics Corporation20243—
+7K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+7K241396uCerv Flux™-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA, Inc.20240—
+7K240699SCARLET® AC-TiSpineart SA20240—
+7K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+7K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+7K234150Lucent® XPSpinal Elements20240—
+7K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+7K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+7K233694Meridian Interbody System; WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20248—
+7K230872Halis™ Lumbar Cage System, Lydia™ Anterior Lumbar Fusion System, Dica™ Direction…Shanghai Sanyou Medical Co, Ltd.20231—
+7K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+7K230478Acro Composites Interbody SystemAcro Composites, LLC20230—
+7K231486Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20231—
+7K232530Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC20235—
+7K232150ZSFab Cervical Interbody SystemZsfab, Inc.20234—
+7K230607SPICCA Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+7K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+7K230894NuVasive Modulus ALIF SystemNu Vasive, Incorporated20234—
+7K220261NEST-C Interbody SystemPaonan Biotech Co., Ltd.20230—
+7K230583Tryptik TiSpineart SA20231—
+7K223731NuVasive Modulus-C Interbody SystemNuvasive, Inc.202311—
+7K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+7K222732WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20229—
+7K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+7K221751NuVasive Cohere ALIF System Intervertebral Body Fusion DeviceNu Vasive, Incorporated20223—
+7K222203DualXSLIM (R) T/PLIFAmplify Surgical, Inc.20223—
+7K221646CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™…Medtronic Sofamor Danek USA, Inc.202220—
+7K222561AlignAcuity Surgical Devices, LLC202214—
+7K221325CONDUIT Lateral Switch PlateMedos International SARL20221—
+7K220696uCerv Flux-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA20221—
+7K221535Align Lumbar Interbody Fusion SystemAcuity Surgical Devices, LLC20223—
+7K220523restor3d TiDAL Lumbar Interbody Fusion DeviceRestor3D20222—
+7K220610SOLO-LAurora Spine, Inc.20220—
+7K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+7K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC20223—
+7K213118Dakota ALIF SystemPrecision Spine, Inc.20220—
+7K220453FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20221—
+7K213980Peridot Spinal Interbody SystemGbs Commonwealth Co., Ltd.20224—
+7K203714NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System…Nu Vasive, Incorporated202166—
+7K210590Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20210—
+7K211740DualXAmplify Surgical, Inc.20211—
+7K211805IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec…Alphatec Spine, Inc.202138—
+7K210470C-CURVE Interbody Fusion DeviceMedicrea International SA20210—
+7K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+7K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+7K211258Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA…Medtronic Sofamor Danek USA, Inc.202175—
+7K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemNu Vasive, Incorporated20213—
+7K210061ProLift Lateral HELO FixatedLife Spine, Inc.20213—
+7K200919Idys ALIF 3DTiClariance20210—
+7K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+7K202032Idys LLIF 3DTiClariance, Sas20210—
+7K203038Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20215—
+7K203361ProLift Wedge Expandable Spacer SystemLife Spine, Inc.20211—
+7K210271NuVasive Modulus ALIF SystemNu Vasive, Incorporated20215—
+7K202872Prase PEEK Anterior Cervical Interbody SpacerGbs Commonwealth Co., Ltd.20215—
+7K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135—
+7K202488ZSFab Cervical Interbody SystemZsfab, Inc.20216—
+7K202298Lucent XP, Lucent XP CurvedSpinal Elements, Inc.20202—
+7K200549Lucero Medical Cervical Cage SystemLucero Medical, LLC20200—
+7K201755WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody SystemSeaSpine Orthopedics Corporation202017—
+7K201692NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated202067—
+7K200953NuVasive® Cohere® Thoracolumbar Interbody SystemNu Vasive, Incorporated2020141—
+7K202190Oculus-SA Lumbar Cage SystemNeurostructures20200—
+7K192863MONDRIAN Lumbar Interbody Fusion Cage SystemCtl Medical Corporation20203—
+7K201087CORBEL SpacersGlobus Medical, Inc.202036—
+7K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+7K200920Idys ALIF ZP 3DTiClariance, Sas20203—
+7K200352Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20202—
+7K192492EL CAPITAN Anterior Lumber Interbody SystemAstura Medical, LLC202010—
+7K200338ProLift Lateral FixatedLife Spine, Inc.20205—
+7K200613Tritanium® X TL Expandable Curved Posterior Lumbar CageStryker Corporation20205—
+7K193541NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2020157—
+7K192897icotec Cervical CageIcotec AG20201—
+7K193506NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR SystemNu Vasive, Incorporated20201—
+7K193255Largo PEEK Interbody SystemFlospine, LLC20201—
+7K192993Scarlet AL-TSpineart20201—
+7K191581Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion…Titan Spine, Inc.202081—
+7K193359SureMAX Family of Cervical SpacersAdditive Implants, Inc.202014—
+7K191834Stand-Alone ALIF Titanium SystemLife Spine, Inc.20190—
+7K192336Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.201917—
+7K191477AEON-C Stand Alone SystemHuvexel Co., Ltd.201910—
+7K192168Idys ALIF ZP 3DTiClariance, Sas20195—