510(k) Report

Devices descending from K081391

171 later devices reach Vip Anterior Cervical Plate System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K220334MONET Anterior Cervical Plate SystemCtl Medical Corporation20220—
+1K181846ASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical Plate System, VIP…Globus Medical, Inc.20184—
+1K173099Fortis and Hana Anterior Cervical Plate SystemHuvexel Co., Ltd.20174—
+1K142218Coalition AGX Plate and Coalition AGX SpacerGlobus Medical, Inc.2015155—
+1K092146Xtend Anterior Cervical Plate SystemGlobus Medical, Inc.200911—
+2K250764SpineLinc Anterior Cervical Implant SystemLincotek Medical20250—
+2K250769Dakota LP SystemPrecision Spine, Inc.20250—
+2K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+2K222572FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, and…Dio Medical Corporation20222—
+2K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+2K220379IMPEACE and IMPEACE-Uni Anterior Cervical Plate SystemMedynus, Inc.20220—
+2K192314RESONATE Anterior Cervical Plate SystemGlobus Medical, Inc.20193—
+2K191584FORTICO Anterior Cervical Fixation SystemCamber Spine Technologies, LLC20192—
+2K191243HEDRON Cervical SpacersGlobus Medical, Inc.201936—
+2K190885Elevation Spine Saber-C SystemElevation Spine201925—
+2K173115COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and…Globus Medical, Inc.201783—
+2K152022SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION®…Globus Medical, Inc.2017149—
+2K152793Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.201629—
+2K121049Unify Dynamic Anterior Cervical Plate SystemGlobus Medical, Inc.201210—
+3K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+3K260660SABER-C SystemElevation Spine20261—
+3K253260ORIO-3D Cage SystemSpineCraft20260—
+3K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+3K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—
+3K250540SABER-C SystemElevation Spine20252—
+3K250446Frida™ Anterior Cervical Plate SystemSpineup, Inc.20250—
+3K231251FlexWing Anterior Cervical Plate SystemJeil Medical Corporation20242—
+3K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+3K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+3K231147Hammerdesis™ Interphalangeal Fusion SystemIntelivation20230—
+3K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+3K231460FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System…K&J Consulting Corp.20230—
+3K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+3K223190Hive™ Standalone Cervical SystemNanoHive Medical, LLC20225—
+3K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+3K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+3K211903Shoreline Threaded TruProfile® PlateSeaSpine Orthopedics Corporation20217—
+3K211205Prase-C Anterior Cervical Plate SystemGbs Commonwealth Co., Ltd.20210—
+3K210382Blustone Synergy Diamond SA Cervical SystemBlustone Synergy, LLC20210—
+3K203129NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) SystemPrecision Spine, Inc.20210—
+3K203076Mecta-C Stand Alone ExtensionMedacta International S.A.20200—
+3K202065DOLOMITE Anterior Cervical Stabilization SystemAstura Medical, LLC20203—
+3K201073Seaspine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202017—
+3K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC202025—
+3K191477AEON-C Stand Alone SystemHuvexel Co., Ltd.201910—
+3K180909REVEL SpacersGlobus Medical, Inc.201837—
+3K181357PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc.201897—
+3K171567IRIX-A Lumbar Integrated Fusion SystemX-Spine Systems, Inc.201701
+3K170830Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20175—
+3K133567Unify (R) Dynamic Anterior Cervical Plate SystemGlobus Medical, Inc.20145—
+4K263049SABER-C SystemElevation Spine20260—
+4K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+4K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+4K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+4K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+4K252826ARIX Femur Nail SystemJeil Medical Corporation20250—
+4K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+4K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+4K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+4K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+4K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+4K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+4K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+4K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+4K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+4K241846E3D™-C Interbody SystemEvolution Spine20246—
+4K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+4K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+4K232348RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion SystemMiRus, LLC20231—
+4K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+4K230329F3D Interbody SystemCorelink, LLC20230—
+4K223140AEON-C™ Stand Alone SystemDio Medical, Inc.20222—
+4K212904SeaSpine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202115—
+4K213359SeaSpine WaveForm, C Interbody SystemSeaSpine Orthopedics Corporation20217—
+4K212853Cervical Stand-Alone SystemEminent Spine, LLC202118—
+4K201453Fortilink Cages with TiPlus TechnologyParadigm Spine GmbH20204—
+4K192115SABLE Expandable SpacerGlobus Medical, Inc.202037—
+4K191391HEDRON Lumbar SpacersGlobus Medical, Inc.201984—
+5K261049Scala® TLSpineart SA20260—
+5K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—
+5K262094E3D™-C Interbody SystemEvolution Spine20260—
+5K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+5K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+5K260837VersaLift Expandable SystemLife Spine, Inc.20260—
+5K260038E3D™-C Interbody SystemEvolution Spine20261—
+5K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+5K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+5K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+5K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+5K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+5K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+5K233947KLIMT™ Expandable Lumbar Interbody Fusion (LIF) Cage SystemCtl Medical Corporation20240—
+5K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+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—
+5K240838Spectrum Spine Cervical Cage SystemSpectrum Spine, Inc.20244—
+5K240368E3D™-A Interbody SystemEvolution Spine20247—
+5K232877FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous…K&J Consulting Corporation20231—
+5K233414Shoreline ACS Interbody System; Shoreline RT Interbody SystemSeaSpine Orthopedics Corporation20238—
+5K230608SPICCA Stand-Alone Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—