510(k) Report

Devices descending from K040197

215 later devices reach Eagle Anterior Cervial Plate System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K153526Pyrenees Cervical Plate SystemK2m20166—
+1K100070Uniplate Anterior Cervical Plate SystemDepuy Spine, Inc.201047—
+1K082273Uniplate Anterior Cervical Plate SystemDepuy Spine, Inc.200850—
+1K080646C-Tek Maxan Anterior Cervical Plate SystemBiomet Spine20081932
+1K070994Eagle + Anterior Cervical Plate SystemDepuy Spine, Inc.2007204—
+2K250446Frida™ Anterior Cervical Plate SystemSpineup, Inc.20250—
+2K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+2K213456Xenco Medical Multilevel CerviKitXenco Medical, LLC20210—
+2K192494NexGen Anterior Cervical Plate SystemPrecision Spine20190—
+2K191786Cyclops™ Anterior Cervical Plate SystemDegen Medical, Inc.20191—
+2K190170MVP Cervical Plate SystemGS Medical Co., Ltd.20190—
+2K181471ACCUFUSE Cervical SystemAbsolute Advantage Medical, LLC20180—
+2K171439EAGLE Plus Anterior Cervical Plate System, EAGLE Plus Micro Anterior Cervical Plate…Medos International SARL20170—
+2K162194MEDICREA INTERNATIONAL Anterior Cervical Locking Plate SystemMedicrea International SA20160—
+2K162664Pyrenees Cervical Plate SystemK2m, Inc.20165—
+2K160702ZION Anterior Cervical Fixation SystemAstura Medical20163—
+2K160522White Pearl Preferred Angle Anterior Cervical PlateOsseus Fusion Systems, LLC20160—
+2K151553Anterior Cervical Plate SystemOsteomed Implantes, Ltda201611—
+2K150666uNion Cervical Plate SystemUlrich Medical USA201531
+2K133518Maxan Anterior Cervical Plate SystemBiomet Spine (Aka Ebi, LLC)2014251
+2K131521Velox Anterior Cervical Plate SystemSpinecraft, LLC20130—
+2K133475Struxxure Anterior Cervical Plate and ScrewsNexxt Spine, LLC2013132—
+2K132994Anodyne Anterior Cervical Plate SystemCorelink, LLC20131—
+2K132324Skyline Anterior Cervical Plate System, Uniplate Anterior Cervical Plate System…Medos International SARL20133—
+2K121514Anodyne Anterior Cervical Plate SystemCorelink, LLC201221—
+2K112724Depuy Pulse Anterior Cerical Plate SystemMedos International SARL20112—
+2K081038Atlantis Anterior Cervical Plate SystemMedtronic Sofamor Danek2008353
+2K080191Eagle Plus Micro Anterior Cervical Plate SystemDepuy Spine, Inc.20088—
+2K072546Swift Plus Anterior Cervical Plate SystemDepuy Spine, Inc.2007195—
+3K253545Vulcan Spinal SystemK2m, Inc.20260—
+3K240690STRUXXURE® MCS Anterior Cervical Plate SystemNexxt Spine20244—
+3K240515uNion® MAX Cervical Plate SystemUlrich Medical USA, Inc.20240—
+3K231145Axis Anterior Cervical Plate SystemSouthern Medical (Pty), Ltd.20230—
+3K221053Magnes-C Anterior Cervical Plate SystemFellowship of Orthopaedic Researchers, Inc.20230—
+3K213901Cyclops™ Anterior Cervical Plate SystemDegen Medical20220—
+3K210424Quantum Anterior Cervical PlateNvision Biomedical Technologies, Inc.20214—
+3K210325APOLLO Anterior Cervical Plate (ACP) SystemAurora Spine, Inc.20210—
+3K202227Artus™ cervical plate systemUlrich GmbH & Co. KG20200—
+3K201979Cervical Plate SystemEminent Spine, LLC20201—
+3K200927Transept Cervical Plate SystemNeurostructures, Inc.20200—
+3K201029Sapphire® Spinal System, Sapphire X Anterior Cervical Plate Spinal SystemSpinal Elements, Inc.20201—
+3K200995Insignia™ Anterior Cervical Plate SystemAlphatec Spine, Inc.2020729
+3K191584FORTICO Anterior Cervical Fixation SystemCamber Spine Technologies, LLC20192—
+3K182885Atlantis™ Anterior Cervical Plate, Divergence™ Anterior Cervical Fusion System, Premier™…Medtronic Sofamor Danek USA, Inc.20198—
+3K182473PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System, OZARK Cervical Plate…K2m, Inc.20184—
+3K173306EZ PlateZavation Medical Products, LLC20180—
+3K172585Liberty Anterior Cervical PlateValorus Spine20170—
+3K163104Terrace™ Anterior Cervical Plate SystemCorelink, LLC201718—
+3K162638CETRA Anterior Cervical Plate SystemOrthofix, Inc.20163—
+3K162250FortiBridge Anterior Cervical Plate SystemNanovis Spine, LLC20160—
+3K161524Tangis Anterior Cervical PlateNvision Biomedical Technologies, LLC20168—
+3K150700ACP 1 Anterior Cervical Plating SystemStryker Corporation20150—
+3K141632Zevo (TM) Anterior Cervical Plate SystemMedtronic Sofamor Danek USA, Inc.2014181
+3K141376Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx, Struxxure Anterior…Nexxt Spine, LLC2014106—
+3K140361Meta-C Cervical PlateMedacta International20140—
+3K131512Katia SystemShanghai Sanyou Medical Co, Ltd.20131—
+3K130640Atlantis Anterior Cervical Plate SystemMedtronic Sofamor Danek USA, Inc.201332—
+3K123167Depuy Pulse Anterior Cervical in-Line Plate SystemMedos International SARL20120—
+4K252776ARIES Anterior Cervical Plate SystemsZheJiang Decans Medical Devices Co., Ltd.20260—
+4K252611aprevo® cervical plating systemCarlsmed, Inc.20253—
+4K240935ARENAL Anterior Cervical Plate SystemEffortmed, LLC20240—
+4K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+4K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue®…Lesspine Innovations20230—
+4K231593Sapphire X3 Anterior Cervical Plate SystemSpinal Elements, Inc.20230—
+4K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+4K231090Zevo Anterior Cervical Plate SystemMedtronic Sofamor Danek USA, Inc.20231—
+4K223753Cervical Plate SystemDouble Medical Technology, Inc.20230—
+4K221728Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran™ Anterior…Stryker Corporation20221—
+4K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+4K2117123° Anterior Cervical Plating System, Reliant Anterior Cervical Plating System, Unity…Orthofix US, LLC20220—
+4K213443Insignia™ Anterior Cervical Plate SystemAlphatec Spine, Inc.20216—
+4K211205Prase-C Anterior Cervical Plate SystemGbs Commonwealth Co., Ltd.20210—
+4K202657Javelin Tailor's Bunion Fixation SystemNvision Biomedical Technologies, Inc.20201—
+4K193494Origin™ Anterior Cervical Plate SystemOrthopaedic & Spine Development20200—
+4K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+4K192314RESONATE Anterior Cervical Plate SystemGlobus Medical, Inc.20193—
+4K190016Lateral Plate SystemCorelink, LLC201915—
+4K181190Pinehurst Anterior Cervical Plate SystemSignature Orthopaedics Pty, Ltd.20190—
+4K1824894CIS® Pinehurst Anterior Cervical Plate systemSolco Biomedical Co., Ltd.20191—
+4K181435ATEC Cervical Spacer SystemAlphatec Spine, Inc.2018100—
+4K173091Boundary Anterior Lumbar Buttress PlateNvision Biomedical Technologies, LLC20170—
+4K163366Shanghai Sanyou CARMEN Cervical Fusion SystemShanghai Sanyou Medical Co, Ltd.20170—
+4K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+4K152623ATLANTIS Anterior Cervical Plate SystemMedtronic Sofamor Danek USA, Inc.20159—
+4K143706FortiBridge Anterior Cervical Plate SystemNanovis Spine, LLC20151—
+4K141599Divergence Anterior Cervical Fusion SystemMedtronic Sofamor Danek USA, Inc.201516—
+4K140417Divergence Mini-Plate Anterior Cervical Fusion SystemMedtronic Sofamor Danek, Inc.201411—
+5K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+5K260570corra™ cervical plating systemCarlsmed, Inc.20261—
+5K260291Vortex5 Tailor's Bunion Correction SystemNvision Biomedical Technologies, Inc.20260—
+5K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+5K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+5K241164IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic)202412
+5K242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemEminent Spine20240—
+5K231251FlexWing Anterior Cervical Plate SystemJeil Medical Corporation20242—
+5K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+5K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+5K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+5K230424Omnia Medical Coupler-A™ Anterior Lumbar Plate System; Omnia Medical Coupler-L™ Lateral…Omnia Medical, LLC20230—
+5K223321Omnia Medical Coupler-C Anterior Cervical PlateOmnia Medical, LLC20230—