510(k) Report

Devices descending from K971730

394 later devices reach Depuy Motech Peak Polyaxial Anterior Cervical Plate System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K150983Pyrenees Cervical Plate SystemK2m20157—
+1K103505Altum Anterior Cervical PlateSpinecraft, LLC201111
+1K092474Pyrenees Cervical Plate System, Semi-Constrained ScrewsK2m, Inc.20108—
+1K063544Modification to Pyrenees Cervical Plate SystemK2m, Inc.200738—
+1K043066Pioneer Anterior Cervical Plate SystemPioneer Surgical Technology200527—
+1K040721Assure Anterior Cervical Plate SystemGlobus Medical, Inc.2004178—
+1K040655Swift Anterior Cervical Plate SystemDepuy Spine, Inc.2004217—
+1K040197Eagle Anterior Cervial Plate SystemDepuyacromed2004215—
+1K013439Anterior Cervical Plate SystemScien'Tx USA, Inc.200264—
+2K192314RESONATE Anterior Cervical Plate SystemGlobus Medical, Inc.20193—
+2K181846ASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical Plate System, VIP…Globus Medical, Inc.20184—
+2K162664Pyrenees Cervical Plate SystemK2m, Inc.20165—
+2K153526Pyrenees Cervical Plate SystemK2m20166—
+2K152281Pyrenees Cervical Plate SystemK2m20156—
+2K152015Pyrenees Cervical Plate SystemK2m, Inc.20150—
+2K142212Pyrenees Cervical Plate SystemK2m, Inc.20150—
+2K133567Unify (R) Dynamic Anterior Cervical Plate SystemGlobus Medical, Inc.20145—
+2K131521Velox Anterior Cervical Plate SystemSpinecraft, LLC20130—
+2K121049Unify Dynamic Anterior Cervical Plate SystemGlobus Medical, Inc.201210—
+2K113329K2M, Pyrenees Cervical Plate SystemK2m, Inc.201228—
+2K111135Pyrenees Cervical Plate System (Translational Plates)K2m, Inc.20111—
+2K100708Pioneer Anterior Cervical Plate Model 24-SeriesPioneer Surgical Technology201012—
+2K100215Archimed Remedy Cervical PlateArchimed, Inc.20100—
+2K100070Uniplate Anterior Cervical Plate SystemDepuy Spine, Inc.201047—
+2K092146Xtend Anterior Cervical Plate SystemGlobus Medical, Inc.200911—
+2K083663PACPPioneer Surgical Technology200917—
+2K082273Uniplate Anterior Cervical Plate SystemDepuy Spine, Inc.200850—
+2K081391Vip Anterior Cervical Plate SystemGlobus Medical, Inc.2008171—
+2K073500Active Anterior Cervical Plate SystemSanacor20080—
+2K080646C-Tek Maxan Anterior Cervical Plate SystemBiomet Spine20081932
+2K072546Swift Plus Anterior Cervical Plate SystemDepuy Spine, Inc.2007195—
+2K070994Eagle + Anterior Cervical Plate SystemDepuy Spine, Inc.2007204—
+2K070775Modification to: Providence Anterior Cervical Plate SystemGlobus Medical, Inc.2007177—
+2K053053Pacp SystemPioneer Surgical Technology200525—
+2K042317Cervical PlateScient'X200463—
+3K250446Frida™ Anterior Cervical Plate SystemSpineup, Inc.20250—
+3K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+3K231251FlexWing Anterior Cervical Plate SystemJeil Medical Corporation20242—
+3K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+3K223321Omnia Medical Coupler-C Anterior Cervical PlateOmnia Medical, LLC20230—
+3K220334MONET Anterior Cervical Plate SystemCtl Medical Corporation20220—
+3K213456Xenco Medical Multilevel CerviKitXenco Medical, LLC20210—
+3K200224SEA-LINK Anterior Cervical Plate SystemIndius Medical Technologies Pvt., Ltd.20200—
+3K192494NexGen Anterior Cervical Plate SystemPrecision Spine20190—
+3K191584FORTICO Anterior Cervical Fixation SystemCamber Spine Technologies, LLC20192—
+3K191786Cyclops™ Anterior Cervical Plate SystemDegen Medical, Inc.20191—
+3K190170MVP Cervical Plate SystemGS Medical Co., Ltd.20190—
+3K181190Pinehurst Anterior Cervical Plate SystemSignature Orthopaedics Pty, Ltd.20190—
+3K183060CervAlign™ Anterior Cervical Plate SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)201921
+3K182473PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System, OZARK Cervical Plate…K2m, Inc.20184—
+3K181471ACCUFUSE Cervical SystemAbsolute Advantage Medical, LLC20180—
+3K173099Fortis and Hana Anterior Cervical Plate SystemHuvexel Co., Ltd.20174—
+3K172104Ozark (tm) Cervical Plate SystemK2m, Inc.20175—
+3K171439EAGLE Plus Anterior Cervical Plate System, EAGLE Plus Micro Anterior Cervical Plate…Medos International SARL20170—
+3K162194MEDICREA INTERNATIONAL Anterior Cervical Locking Plate SystemMedicrea International SA20160—
+3K160702ZION Anterior Cervical Fixation SystemAstura Medical20163—
+3K160522White Pearl Preferred Angle Anterior Cervical PlateOsseus Fusion Systems, LLC20160—
+3K151553Anterior Cervical Plate SystemOsteomed Implantes, Ltda201611—
+3K152282Cam Lock Plating SystemLife Spine, Inc.20151—
+3K150666uNion Cervical Plate SystemUlrich Medical USA201531
+3K142218Coalition AGX Plate and Coalition AGX SpacerGlobus Medical, Inc.2015155—
+3K133518Maxan Anterior Cervical Plate SystemBiomet Spine (Aka Ebi, LLC)2014251
+3K133475Struxxure Anterior Cervical Plate and ScrewsNexxt Spine, LLC2013132—
+3K132994Anodyne Anterior Cervical Plate SystemCorelink, LLC20131—
+3K132324Skyline Anterior Cervical Plate System, Uniplate Anterior Cervical Plate System…Medos International SARL20133—
+3K130427Pioneer Aspect Anterior Cervical Plate SystemPioneer Surgical Technology, Inc.20135—
+3K130202Iris Anterior Cervical PlateLife Spine, Inc.201321—
+3K121514Anodyne Anterior Cervical Plate SystemCorelink, LLC201221—
+3K122216Reliance Anterior Cervical Plate SystemReliance Medical Systems, LLC20123—
+3K112724Depuy Pulse Anterior Cerical Plate SystemMedos International SARL20112—
+3K111528Pioneer Aspect Anterior Cervical Plate Model 24-SeriesPioneer Surgical Technology, Inc.201111—
+3K081038Atlantis Anterior Cervical Plate SystemMedtronic Sofamor Danek2008353
+3K080191Eagle Plus Micro Anterior Cervical Plate SystemDepuy Spine, Inc.20088—
+3K072703Pioneer Slimfuse Anterior Cervical Plating SystemPioneer Surgical Technology200819—
+3K070681Next Generation Anterior Cervical Plating SystemAlphatec Spine, Inc.2007621
+4K253545Vulcan Spinal SystemK2m, Inc.20260—
+4K252826ARIX Femur Nail SystemJeil Medical Corporation20250—
+4K250764SpineLinc Anterior Cervical Implant SystemLincotek Medical20250—
+4K250769Dakota LP SystemPrecision Spine, Inc.20250—
+4K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+4K243369Cervical Plating SystemLife Spine, Inc.20240—
+4K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+4K240690STRUXXURE® MCS Anterior Cervical Plate SystemNexxt Spine20244—
+4K240515uNion® MAX Cervical Plate SystemUlrich Medical USA, Inc.20240—
+4K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+4K231145Axis Anterior Cervical Plate SystemSouthern Medical (Pty), Ltd.20230—
+4K221053Magnes-C Anterior Cervical Plate SystemFellowship of Orthopaedic Researchers, Inc.20230—
+4K221728Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran™ Anterior…Stryker Corporation20221—
+4K222572FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, and…Dio Medical Corporation20222—
+4K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+4K221572VyPlate Anterior Cervical Plate SystemVy Spine, LLC20221—
+4K220379IMPEACE and IMPEACE-Uni Anterior Cervical Plate SystemMedynus, Inc.20220—
+4K213901Cyclops™ Anterior Cervical Plate SystemDegen Medical20220—
+4K210424Quantum Anterior Cervical PlateNvision Biomedical Technologies, Inc.20214—
+4K211205Prase-C Anterior Cervical Plate SystemGbs Commonwealth Co., Ltd.20210—
+4K211408CervAlign® Anterior Cervical Plate SystemPioneer Surgical Technology, Inc.20211—
+4K210325APOLLO Anterior Cervical Plate (ACP) SystemAurora Spine, Inc.20210—
+4K202227Artus™ cervical plate systemUlrich GmbH & Co. KG20200—
+4K201979Cervical Plate SystemEminent Spine, LLC20201—
+4K200927Transept Cervical Plate SystemNeurostructures, Inc.20200—