510(k) Report

Devices descending from K021461

157 later devices reach Atlantis Vision Anterior Cervical Plate System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K252776ARIES Anterior Cervical Plate SystemsZheJiang Decans Medical Devices Co., Ltd.20260—
+1K203154KASILOF Cervical Plate SystemKahtnu Surgical, Inc.20200—
+1K182885Atlantis™ Anterior Cervical Plate, Divergence™ Anterior Cervical Fusion System, Premier™…Medtronic Sofamor Danek USA, Inc.20198—
+1K173867Axis Anterior Cervical Plate SystemAxis Orthopaedics20181—
+1K152623ATLANTIS Anterior Cervical Plate SystemMedtronic Sofamor Danek USA, Inc.20159—
+1K131025Archon Anterior Cervical Plate SystemNuvasive, Inc.201397—
+1K130640Atlantis Anterior Cervical Plate SystemMedtronic Sofamor Danek USA, Inc.201332—
+1K110990Gso ACP1 Anterior Cervical Plate SystemGold Standard Orthopedics, LLC20110—
+1K103070GPS TM, G Surgical Anterior Cervical Plate System +G Surgical Co., Ltd.20110—
+1K092695Transcorp Trans-Plate Anterior Cervical Plate SystemTranscorp, Inc.20100—
+1K100215Archimed Remedy Cervical PlateArchimed, Inc.20100—
+1K081038Atlantis Anterior Cervical Plate SystemMedtronic Sofamor Danek2008353
+1K071990Valeo Cervical Plate SystemAmedica Corp.20071—
+1K063100Atlantis Anterior Cervical Plate System, Translational PlateMedtronic Sofamor Danek, Inc.2007503
+2K212527Cervical Spine Truss System Plating Solution (CSTS-PS)4Web Medical, Inc.20220—
+2K212446NuVasive Anterior Cervical Plate SystemsNu Vasive, Incorporated20211—
+2K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+2K191584FORTICO Anterior Cervical Fixation SystemCamber Spine Technologies, LLC20192—
+2K161641LOSPA IS ACP SystemCorentec Co., Ltd.20170—
+2K161442NuVasive® CoRoent® Small Interlock™ SystemNu Vasive, Incorporated201694—
+2K143706FortiBridge Anterior Cervical Plate SystemNanovis Spine, LLC20151—
+2K141599Divergence Anterior Cervical Fusion SystemMedtronic Sofamor Danek USA, Inc.201516—
+2K141632Zevo (TM) Anterior Cervical Plate SystemMedtronic Sofamor Danek USA, Inc.2014181
+2K140417Divergence Mini-Plate Anterior Cervical Fusion SystemMedtronic Sofamor Danek, Inc.201411—
+2K140361Meta-C Cervical PlateMedacta International20140—
+2K131512Katia SystemShanghai Sanyou Medical Co, Ltd.20131—
+2K121049Unify Dynamic Anterior Cervical Plate SystemGlobus Medical, Inc.201210—
+2K092474Pyrenees Cervical Plate System, Semi-Constrained ScrewsK2m, Inc.20108—
+2K082037Seeplate Cervical Plate SystemAmedica Corp.20080—
+3K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+3K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+3K241164IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic)202412
+3K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+3K231090Zevo Anterior Cervical Plate SystemMedtronic Sofamor Danek USA, Inc.20231—
+3K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+3K223753Cervical Plate SystemDouble Medical Technology, Inc.20230—
+3K212358Romero Cervical CageSpineup, Inc.20226—
+3K211205Prase-C Anterior Cervical Plate SystemGbs Commonwealth Co., Ltd.20210—
+3K192314RESONATE Anterior Cervical Plate SystemGlobus Medical, Inc.20193—
+3K1824894CIS® Pinehurst Anterior Cervical Plate systemSolco Biomedical Co., Ltd.20191—
+3K181846ASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical Plate System, VIP…Globus Medical, Inc.20184—
+3K173115COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and…Globus Medical, Inc.201783—
+3K163366Shanghai Sanyou CARMEN Cervical Fusion SystemShanghai Sanyou Medical Co, Ltd.20170—
+3K170961NuVasive CoRoent Small Interlock II SystemNu Vasive, Incorporated201718—
+3K162250FortiBridge Anterior Cervical Plate SystemNanovis Spine, LLC20160—
+3K152281Pyrenees Cervical Plate SystemK2m20156—
+3K142212Pyrenees Cervical Plate SystemK2m, Inc.20150—
+3K142450DIVERGENCE Anterior Cervical Fusion SystemMedtronic Sofamor Danek USA, Inc.20146—
+3K133567Unify (R) Dynamic Anterior Cervical Plate SystemGlobus Medical, Inc.20145—
+4K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+4K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+4K253577IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)Medicrea International S.A.S. (Medtronic)20250—
+4K231251FlexWing Anterior Cervical Plate SystemJeil Medical Corporation20242—
+4K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—
+4K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+4K231735NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody…Nu Vasive, Incorporated20239—
+4K230026SqualeImplanet, S.A.20230—
+4K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+4K223321Omnia Medical Coupler-C Anterior Cervical PlateOmnia Medical, LLC20230—
+4K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+4K210382Blustone Synergy Diamond SA Cervical SystemBlustone Synergy, LLC20210—
+4K203076Mecta-C Stand Alone ExtensionMedacta International S.A.20200—
+4K202065DOLOMITE Anterior Cervical Stabilization SystemAstura Medical, LLC20203—
+4K201073Seaspine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202017—
+4K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC202025—
+4K191477AEON-C Stand Alone SystemHuvexel Co., Ltd.201910—
+4K191243HEDRON Cervical SpacersGlobus Medical, Inc.201936—
+4K190885Elevation Spine Saber-C SystemElevation Spine201925—
+4K180909REVEL SpacersGlobus Medical, Inc.201837—
+4K181621Stable-C Interbody SystemNexus Spine, LLC20187—
+4K172104Ozark (tm) Cervical Plate SystemK2m, Inc.20175—
+5K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+5K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+5K260660SABER-C SystemElevation Spine20261—
+5K253260ORIO-3D Cage SystemSpineCraft20260—
+5K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC20260—
+5K252826ARIX Femur Nail SystemJeil Medical Corporation20250—
+5K250764SpineLinc Anterior Cervical Implant SystemLincotek Medical20250—
+5K250769Dakota LP SystemPrecision Spine, Inc.20250—
+5K252686EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC20251—
+5K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—
+5K250540SABER-C SystemElevation Spine20252—
+5K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+5K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+5K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+5K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+5K241846E3D™-C Interbody SystemEvolution Spine20246—
+5K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc.20242—
+5K232348RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion SystemMiRus, LLC20231—
+5K231147Hammerdesis™ Interphalangeal Fusion SystemIntelivation20230—
+5K231763Stable-C Interbody SystemNexus Spine, LLC20236—
+5K230329F3D Interbody SystemCorelink, LLC20230—
+5K223140AEON-C™ Stand Alone SystemDio Medical, Inc.20222—
+5K223190Hive™ Standalone Cervical SystemNanoHive Medical, LLC20225—
+5K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+5K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+5K212904SeaSpine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202115—
+5K213359SeaSpine WaveForm, C Interbody SystemSeaSpine Orthopedics Corporation20217—
+5K212853Cervical Stand-Alone SystemEminent Spine, LLC202118—
+5K211903Shoreline Threaded TruProfile® PlateSeaSpine Orthopedics Corporation20217—