510(k) Report

Devices descending from K040422

1,002 later devices reach Modification to Verte-Stack through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+8K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+8K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+8K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc.20251—
+8K241525ExcelsiusXR™Globus Medical, Inc.20250—
+8K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+8K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+8K251459OneLIF™ Interbody Fusion SystemNovapproach Spine, LLC20250—
+8K243386Ventris Intervertebral Body Fusion DeviceAcuity Surgical Devices, LLC20252—
+8K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+8K250605EVOL® ha – Hyper C Cervical Interbody Fusion SystemCutting Edge Spine, LLC20250—
+8K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+8K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+8K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+8K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+8K241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc.20241—
+8K242734ZSFab Cervical Interbody System; ZSFab Lumbar Interbody SystemZsfab20243—
+8K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+8K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+8K242589Scarlet® AL-TSpineart SA20240—
+8K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+8K233947KLIMT™ Expandable Lumbar Interbody Fusion (LIF) Cage SystemCtl Medical Corporation20240—
+8K242826ProLift Wedge Expandable Spacer SystemLife Spine, Inc.20240—
+8K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+8K241846E3D™-C Interbody SystemEvolution Spine20246—
+8K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+8K241321Juliet® Ti LL Lumbar Interbody DeviceSpineart SA20240—
+8K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+8K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc.20242—
+8K241466Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System…SeaSpine Orthopedics Corporation20243—
+8K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+8K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+8K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+8K234150Lucent® XPSpinal Elements20240—
+8K240715Idys® C ZP 3DTiClariance20240—
+8K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+8K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+8K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+8K233694Meridian Interbody System; WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20248—
+8K233078Posterior Cervical Spine SystemDouble Medical Technology, Inc.20231—
+8K233191TotalTi ACDF by SAGICOSpinal Analytics & Geometrical Implant Co, LLC20230—
+8K233366SYMPHONY OCT SystemMedos International SARL20230—
+8K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+8K232348RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion SystemMiRus, LLC20231—
+8K231704Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer SystemLife Spine, Inc.20230—
+8K231486Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20231—
+8K232530Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC20235—
+8K221138Titus Titanium Cervical by SAGICOSagico VA USA, LLC20231—
+8K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+8K231808QUASAR Standalone ACIF SystemGS Medical Co., Ltd.20230—
+8K231735NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody…Nu Vasive, Incorporated20239—
+8K221307Edge Upper Cervical SystemSpinal Simplicity, LLC20230—
+8K222015Integral Titanium Cervical InterbodyNvision Biomedical Technologies, Inc.20231—
+8K230894NuVasive Modulus ALIF SystemNu Vasive, Incorporated20234—
+8K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+8K230329F3D Interbody SystemCorelink, LLC20230—
+8K230614Cortium™Ulrich Medical USA20230—
+8K220261NEST-C Interbody SystemPaonan Biotech Co., Ltd.20230—
+8K230026SqualeImplanet, S.A.20230—
+8K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+8K230583Tryptik TiSpineart SA20231—
+8K223231Ti-Largo Cervical Interbody SystemFlospine20230—
+8K220296Manta Ray TDF SpacerSeaSpine Orthopedics Corporation20231—
+8K223731NuVasive Modulus-C Interbody SystemNuvasive, Inc.202311—
+8K223105Tesera-K SC SystemKyocera Medical Technologies, Inc.20225—
+8K222806Kodiak C Spinal Implant SystemMet One Technologies, LLC20221—
+8K223140AEON-C™ Stand Alone SystemDio Medical, Inc.20222—
+8K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+8K221578Hexanium ACIFSpinevision, S.A.S.20224—
+8K222732WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20229—
+8K221162UniVy OsteoVy Cervical IBF SystemVy Spine, LLC20222—
+8K221751NuVasive Cohere ALIF System Intervertebral Body Fusion DeviceNu Vasive, Incorporated20223—
+8K222203DualXSLIM (R) T/PLIFAmplify Surgical, Inc.20223—
+8K222561AlignAcuity Surgical Devices, LLC202214—
+8K221325CONDUIT Lateral Switch PlateMedos International SARL20221—
+8K221535Align Lumbar Interbody Fusion SystemAcuity Surgical Devices, LLC20223—
+8K220523restor3d TiDAL Lumbar Interbody Fusion DeviceRestor3D20222—
+8K220581Zavation eZspand Interbody SystemZavation Medical Products, LLC20224—
+8K220610SOLO-LAurora Spine, Inc.20220—
+8K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+8K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC20223—
+8K213118Dakota ALIF SystemPrecision Spine, Inc.20220—
+8K202266Reliance Cervical IBF SystemReliance Medical Systems, LLC20223—
+8K220453FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20221—
+8K213980Peridot Spinal Interbody SystemGbs Commonwealth Co., Ltd.20224—
+8K203714NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System…Nu Vasive, Incorporated202166—
+8K212904SeaSpine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202115—
+8K213359SeaSpine WaveForm, C Interbody SystemSeaSpine Orthopedics Corporation20217—
+8K211845Deploy Expandable Interbody SystemSouthern Spine, LLC20210—
+8K212853Cervical Stand-Alone SystemEminent Spine, LLC202118—
+8K210590Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20210—
+8K211740DualXAmplify Surgical, Inc.20211—
+8K211805IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec…Alphatec Spine, Inc.202138—
+8K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+8K210800IO Expandable Lumbar Interbody Fusion SystemMiRus, LLC20212—
+8K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+8K211111SureMAX-SA Cervical Standalone SystemAdditive Implants, Inc.20218—
+8K210497SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202139—
+8K211441Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.20219—
+8K211258Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA…Medtronic Sofamor Danek USA, Inc.202175—