510(k) Report

Devices descending from P960025

1,714 later devices reach Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle Screws through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K222806Kodiak C Spinal Implant SystemMet One Technologies, LLC20221—
+3K2136534CIS Black Marlin Plif Cage System, 4CIS Dolphin Tlif Cage SystemSolco Biomedical Company India Private Limited20220—
+3K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc.20221—
+3K222903Tailored-H Cervical Stand Alone SystemBespoke Technologies, LLC20220—
+3K221545MectaLIF Anterior ExtensionMedacta International S.A.202226
+3K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+3K222203DualXSLIM (R) T/PLIFAmplify Surgical, Inc.20223—
+3K222797X-Pac Expandable Lumbar Cage SystemExpanding Innovations, Inc.20221—
+3K221172FOCUS Interbody SystemOc Medical Devices20220—
+3K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+3K213417Ghost Spacer SystemLife Spine, Inc.20220—
+3K213641MONDRIAN ALIF Cage with Supplementary Fixation PlateCtl Medical Corporation20221—
+3K213791Unispace SA Cervical CageEdisoninno Co., Ltd.20222—
+3K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+3K220523restor3d TiDAL Lumbar Interbody Fusion DeviceRestor3D20222—
+3K212450Keos Anterior Cervical Interbody Fusion Device SystemKeos20220—
+3K220581Zavation eZspand Interbody SystemZavation Medical Products, LLC20224—
+3K221180Anteralign (TM) Spinal System with Titan NanoLOCK Surface Technology Navigated InstrumentsMedtronic Sofamor Danek USA, Inc.20222—
+3K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+3K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC20223—
+3K220655X-Pac Expandable Lumbar Cage SystemExpanding Innovations, Inc.20222—
+3K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20227—
+3K213980Peridot Spinal Interbody SystemGbs Commonwealth Co., Ltd.20224—
+3K213441PathLoc Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20222—
+3K220096Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20220—
+3K212930LumiVy Lumbar IBF SystemVy Spine, LLC20226—
+3K214011Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal…Medtronic Sofamor Danek USA, Inc.20221—
+3K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+3K212653Catalyft LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.202127
+3K210573Velofix SA Cervical CageU&I Corporation20211—
+3K212562Idys-C ZP 3DTiClariance, SA20211—
+3K211805IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec…Alphatec Spine, Inc.202138—
+3K211689KEYSTONE PEEK Cage SystemShanghai Sanyou Medical Co, Ltd.20212—
+3K211474Kleiner KG2 SystemBAAT Medical Products B.V.20210—
+3K210470C-CURVE Interbody Fusion DeviceMedicrea International SA20210—
+3K210090Impulse AM Interbody Fusion SystemDegen Medical20217—
+3K211413BEE PLIF CageNGMedical GmbH20211—
+3K210800IO Expandable Lumbar Interbody Fusion SystemMiRus, LLC20212—
+3K211442StealthStation Spinous Process ClampsMedtronic Navigation20212—
+3K210497SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202139—
+3K203003Pantheon IBFDPantheon Spinal20210—
+3K203802X-Pac Expandable Lumbar Cage SystemExpanding Innovations, Inc.20213—
+3K210583SeaSpine WaveForm™ A Interbody SystemSeaSpine Orthopedics Corporation202114—
+3K211258Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA…Medtronic Sofamor Danek USA, Inc.202175—
+3K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemNu Vasive, Incorporated20213—
+3K203311ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20213—
+3K201671A-Link ZAcuity Surgical Devices, LLC202125—
+3K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+3K202032Idys LLIF 3DTiClariance, Sas20210—
+3K203038Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20215—
+3K202380Born PT-LIF Cage HASpineworxx AG20210—
+3K202872Prase PEEK Anterior Cervical Interbody SpacerGbs Commonwealth Co., Ltd.20215—
+3K203327VERTACONNECT TLIF CageSignus Medizintechnik20210—
+3K203683CarboClear Lumbar Cage SystemCarbofix Orthpedics, Ltd.20211—
+3K203129NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) SystemPrecision Spine, Inc.20210—
+3K202820Australis Anterior Lumbar Cage SystemPrism Surgical Designs Pty, Ltd.20200—
+3K201643ChoiceSpine Tiger Shark Cervical Spacer SystemChoice Spine, LLC20204—
+3K201193SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202018—
+3K193000Hexanium® ACIFSpinevision, S.A.S.202014—
+3K201939GAIA Lumbar Interbody Fusion Device (LIFD) FamilyPrinterprezz20200—
+3K201367FlareHawk TiHawk9 Interbody Fusion SystemIntegrity Implants, Inc.20202—
+3K201769Cavetto [MAX] Cervical Cage SystemNeurostructures, Inc.20200—
+3K201585Monterey AL Interbody SystemStryker Corporation202044
+3K200592GS Medical AnyPlus PEEK Cage SystemGS Medical Co., Ltd.20206—
+3K201500Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar SpacerLife Spine, Inc.20203—
+3K200283Medussa-PL CageMedyssey USA, Inc.20200—
+3K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC202025—
+3K200879SeaSpine Meridian System, SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation202060—
+3K193457AUDERE Lumbar Spacer SystemMet One Technologies20201—
+3K200541Hive™ Stand-alone Anterior Lumbar Interbody SystemHd Lifesciences, LLC20201—
+3K193153SPIRA-C Integrated Fixation SystemCamber Spine Technologies20202—
+3K200312Tryptik TiSpineart20202—
+3K193541NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2020157—
+3K200543NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) SystemNexxt Spine, LLC202072—
+3K192897icotec Cervical CageIcotec AG20201—
+3K200048MectaLIF Anterior SimpleMedacta International S.A.20200—
+3K192906Mecta-C Stand AloneMedacta International S.A.20201—
+3K193378CarboClear Lumbar Cage SystemCarboFix Orthopedics, Ltd.20202—
+3K193521Steerable Plateau TiLife Spine, Inc.20201—
+3K193320KMTI Tesera SA Anterior Lumbar Interbody Fusion (ALIF) SystemKyocera Medical Technologies, Inc.20203—
+3K193645nva, nvp, and nvtNvision Biomedical Technologies, Inc.20203—
+3K190284Bengal Stackable Cage SystemMedos International SARL20190—
+3K1920444CIS Marlin PEEK ACIF CageSolco Biomedical Co., Ltd.20190—
+3K192248Cortina™ [MAX] Lumbar Cage SystemNeurostructures, Inc.20190—
+3K191134IB3D AlifMedicrea International SA20191—
+3K190483SPIRA Open Matrix ALIF and LLIFCamber Spine Technologies20199—
+3K191391HEDRON Lumbar SpacersGlobus Medical, Inc.201984—
+3K190708AccelFix Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20195—
+3K183407Triton CageMedyssey USA, Inc.20190—
+3K192054Endoskeleton TAS PlateTitan Spine, Inc.20190—
+3K191039Navigated T2 STRATOSPHERE Inserters and Navigated TemplatesMedtronic Sofamor Danek USA, Inc.201918—
+3K191565Endoskeleton TCS Interbody Fusion DeviceTitan Spine, Inc.201901
+3K182158UNiD Patient-matched PLIF cageMedicrea International SA201921—
+3K190959ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2019108—
+3K183064TxTi IBF SystemInnovasis, Inc.2019481
+3K190618RIGEL PEEK Anterior Cervical Interbody Fusion SystemMiRus, LLC20191—
+3K190092UNiD Patient specific 3D printed TLIF cageMedicrea International SA201913—
+3K190380nvcNvision Biomedical Technologies, Inc.20193—
+3K183259Idys™ TLIF TiVacClariance, Sas20191—
+3K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc.201999—