510(k) Report

Devices descending from K926453

759 later devices reach Synthes (U.S.a.) Anterior Cervical Vertebrae Plate through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K191786Cyclops™ Anterior Cervical Plate SystemDegen Medical, Inc.20191—
+1K1824894CIS® Pinehurst Anterior Cervical Plate systemSolco Biomedical Co., Ltd.20191—
+1K160604Cure™ Anterior Cervical Plate (ACP) SystemMeditech Spine, LLC20163—
+1K153042TRYPTIK2C-plate Anterior Cervical Plate SystemSpineart201617
+1K113170Cervical PlateEisertech, LLC20121—
+1K101848Sapphire Anterior Cervical Plate SystemSpinal Elements, Inc.20102—
+1K090751Comet Anterior Cervical Plate SystemApollo Spine, Inc.20090—
+1K083338Cardiff Anterior Cervical Plate SystemSeaspine, Inc.200916—
+1K082504Apollo Anterior Cervical Plate SystemApollo Spine, Inc.20091—
+1K071667Synthes Vectra-One SystemSynthes Spine2007263
+1K072650Ist Anterior Cervical Plate SystemInnovative Spinal Technologies, Inc.20078—
+1K040721Assure Anterior Cervical Plate SystemGlobus Medical, Inc.2004178—
+1K990005Spinal Concepts, Inc. (Sci) Anterior Cervical Plate SystemSpinal Concepts, Inc.19993131
+1K971883Synthes Spine Small Stature Anterior Cervical Vertebrae Plate SystemSynthes (Usa)19975311
+1K970048Synthes (Usa)Titanium Locking Plate System (Tilps)Synthes (Usa)199754—
+2K223321Omnia Medical Coupler-C Anterior Cervical PlateOmnia Medical, LLC20230—
+2K213901Cyclops™ Anterior Cervical Plate SystemDegen Medical20220—
+2K210286Cure 2.0 Anterior Cervical Plate (ACP) SystemMeditech Spine, LLC20210—
+2K201029Sapphire® Spinal System, Sapphire X Anterior Cervical Plate Spinal SystemSpinal Elements, Inc.20201—
+2K192314RESONATE Anterior Cervical Plate SystemGlobus Medical, Inc.20193—
+2K190565Cervical PlateEisertech, LLC20190—
+2K181846ASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical Plate System, VIP…Globus Medical, Inc.20184—
+2K181543Cure™ OPEL-C Plate SystemMeditech Spine, LLC20181—
+2K171797TRYPTIK2 C-Plate Anterior Cervical Plate SystemSpineart20180—
+2K170530Butrex Lumbar Buttress Plating SystemX-Spine Systems, Inc.20170—
+2K152239Zero-P Natural Plate SystemSynthes (Usa), LLC20150—
+2K150983Pyrenees Cervical Plate SystemK2m20157—
+2K143626inVizia Anterior Certical Plate System, SC-AcuFix Ant-Cer Dynamic Cervical Plating…Zimmer Spine, Inc.201516—
+2K143576Exactech AmbassadorExactech, Inc.201571
+2K141500Optio-C Anterior Cervical SystemZimmer Spine, Inc.20142—
+2K133567Unify (R) Dynamic Anterior Cervical Plate SystemGlobus Medical, Inc.20145—
+2K131512Katia SystemShanghai Sanyou Medical Co, Ltd.20131—
+2K130427Pioneer Aspect Anterior Cervical Plate SystemPioneer Surgical Technology, Inc.20135—
+2K130030Zavation Cervical Plate SystemZavation, LLC201315—
+2K112748Slimplicity Solo Anterior Cervical Plate SystemSpinal USA, LLC20120—
+2K121049Unify Dynamic Anterior Cervical Plate SystemGlobus Medical, Inc.201210—
+2K112206Cardiff Anterior Cervical Plate SystemSeaspine, Inc.201215—
+2K111796Invizia Anterior Cervical Plate SystemZimmer Spine, Inc.201118—
+2K111135Pyrenees Cervical Plate System (Translational Plates)K2m, Inc.20111—
+2K103287Synthes 6.0 Cocr and CPT TI-3 RodsSynthes Spine2011348—
+2K092474Pyrenees Cervical Plate System, Semi-Constrained ScrewsK2m, Inc.20108—
+2K092146Xtend Anterior Cervical Plate SystemGlobus Medical, Inc.200911—
+2K081418Spinal Elements Buttress Plate SystemSpinal Elements, Inc.20080—
+2K081391Vip Anterior Cervical Plate SystemGlobus Medical, Inc.2008171—
+2K073349Reliance Buttress Washer SystemReliance Medical Systems, LLC20081—
+2K070775Modification to: Providence Anterior Cervical Plate SystemGlobus Medical, Inc.2007177—
+2K063544Modification to Pyrenees Cervical Plate SystemK2m, Inc.200738—
+2K051815Modification to Vertebron SCP Cervical Plate SystemVertebron, Inc.200510—
+2K051665Synthes Vectra-T SystemSynthes Spine2005492
+2K043066Pioneer Anterior Cervical Plate SystemPioneer Surgical Technology200527—
+2K043082The Tosca Anterior Cervical Plate SystemSignus Medizintechnik GmbH20043—
+2K040130Anterior Lumbar Buttress SystemSeaspine20044—
+2K030595Blackstone Fusion Anterior Cervical Plating SystemBlackstone Medical, Inc.200366—
+2K024326Spinal Concepts, Inc. Ant-Cer Dynamic Anterior Cervical Plate SystemSpinal Concepts, Inc.2003194
+2K022344Trinica Select Anterior Cervical Plate SystemCenterpulse Spine-Tech, Inc.2002431
+2K013979SC-Acufix Thinline Anterior Cervical Plate SystemSpinal Concepts, Inc.2002212
+2K012184Blackstone Iii Anterior Cervical Plating SystemBlackstone Medical, Inc.200285—
+2K012881C3 Anterior Cervical Plate SystemSpine Vision, Inc.20014—
+2K010466Tether AcfsTheken Surgical,Llc200143—
+2K000486Abc Cervical Plating SystemAesculap, Inc.2000289—
+2K994383Dogbone AcfsTheken Surgical20000—
+3K231251FlexWing Anterior Cervical Plate SystemJeil Medical Corporation20242—
+3K240592Wolff's Law Anterior Cervical Plate SystemSpinal Simplicity, LLC20240—
+3K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+3K230608SPICCA Stand-Alone Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+3K231593Sapphire X3 Anterior Cervical Plate SystemSpinal Elements, Inc.20230—
+3K221053Magnes-C Anterior Cervical Plate SystemFellowship of Orthopaedic Researchers, Inc.20230—
+3K223719Paeon Anterior Cervical Plate System, Elatus Lumbar Plate SystemAegis Spine, Inc.20233—
+3K220334MONET Anterior Cervical Plate SystemCtl Medical Corporation20220—
+3K2117123° Anterior Cervical Plating System, Reliant Anterior Cervical Plating System, Unity…Orthofix US, LLC20220—
+3K213219Vy Spine™ VyWasher™ Buttress SystemVy Spine, LLC20210—
+3K210182PANAMA™ Anterior Cervical Plate (ACP) SystemFlospine20210—
+3K202064Admiral ACP SystemSeaSpine Orthopedics Corporation202014—
+3K192481AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd.202013—
+3K200927Transept Cervical Plate SystemNeurostructures, Inc.20200—
+3K200523Biolign® Roto-Loc Cervical Plate SystemElite Surgical Supplies (Pty), Ltd.20200—
+3K200224SEA-LINK Anterior Cervical Plate SystemIndius Medical Technologies Pvt., Ltd.20200—
+3K200170SpineNet SSP SystemSpinenet, LLC20200—
+3K191584FORTICO Anterior Cervical Fixation SystemCamber Spine Technologies, LLC20192—
+3K190227Boomerang™ Anterior Cervical Plate SystemChoicespine, LP20194—
+3K181190Pinehurst Anterior Cervical Plate SystemSignature Orthopaedics Pty, Ltd.20190—
+3K183060CervAlign™ Anterior Cervical Plate SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)201921
+3K181549Curiteva Midline Anterior Cervical Plate System (or Curiteva Anterior Cervical Plate…Curiteva, LLC20180—
+3K173867Axis Anterior Cervical Plate SystemAxis Orthopaedics20181—
+3K173099Fortis and Hana Anterior Cervical Plate SystemHuvexel Co., Ltd.20174—
+3K163366Shanghai Sanyou CARMEN Cervical Fusion SystemShanghai Sanyou Medical Co, Ltd.20170—
+3K172104Ozark (tm) Cervical Plate SystemK2m, Inc.20175—
+3K170342Ocata Anterior Cervical SystemKalitec Direct, LLC20171—
+3K170654USS SystemSynthes USA Products, LLC201789—
+3K162638CETRA Anterior Cervical Plate SystemOrthofix, Inc.20163—
+3K162664Pyrenees Cervical Plate SystemK2m, Inc.20165—
+3K153526Pyrenees Cervical Plate SystemK2m20166—
+3K152282Cam Lock Plating SystemLife Spine, Inc.20151—
+3K152455Amendia Cervical Plate SystemAmendia, Inc.20151—
+3K152281Pyrenees Cervical Plate SystemK2m20156—
+3K152015Pyrenees Cervical Plate SystemK2m, Inc.20150—
+3K150666uNion Cervical Plate SystemUlrich Medical USA201531
+3K142212Pyrenees Cervical Plate SystemK2m, Inc.20150—
+3K142218Coalition AGX Plate and Coalition AGX SpacerGlobus Medical, Inc.2015155—
+3K143065NuVasive ALIF Buttress Plate SystemNu Vasive, Incorporated20151—