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
+3K142060Transom Anterior Cervical PlateNeurostructures, Inc.201419—
+3K133245Genesys Spine Anterior Cervical Plate II SystemGenesys Spine201411
+3K140234Aspiron Acp SystemU&I Corp.20146—
+3K132310ASCOTBackroads Consulting, Inc.20130—
+3K131200Aspiron Acp SystemU&I Corporation20137—
+3K132012Trinica (R) Anterior Cervical Plate System, Trinica (R) Select Anterior Cervical Plate…Zimmer Spine, Inc.201322—
+3K124058Creo Stabilization SystemGlobus Medical, Inc.2013172—
+3K121514Anodyne Anterior Cervical Plate SystemCorelink, LLC201221—
+3K122497Asfora Anterior Cervical Plate System, One Level, 14MM Asfora Anterior Cervical Plate…Medical Design, LLC20121—
+3K122910Archon Anterior Cervical Plate Syste,Nu Vasive, Incorporated2012101—
+3K121342Xia 4.5 Spinal SystemStryker Corp.201288—
+3K112809Blue Mountain Cervical PlateQualgenix, LLC20122—
+3K113395Revere 4.5 Stabilization SystemGlobus Medical, Inc.2012260—
+3K113361Securis Spinal FixationCumtom Spine20120—
+3K113149Synthes Uss ConnectorsSynthes Spine201293—
+3K113329K2M, Pyrenees Cervical Plate SystemK2m, Inc.201228—
+3K113044Synthes MirsSynthes Spine2011933
+3K111358Synthes UssSynthes Spine2011151—
+3K112068Synthes Zero-P Variable Angle (VA)Synthes Spine Co.Lp2011331
+3K100243Quintex Cervical Plating SystemAesculap Implant Systems, LLC2010101
+3K100708Pioneer Anterior Cervical Plate Model 24-SeriesPioneer Surgical Technology201012—
+3K090861Mambo, Model CS 18XX-XXUlrich GmbH & Co. KG20100—
+3K100215Archimed Remedy Cervical PlateArchimed, Inc.20100—
+3K083663PACPPioneer Surgical Technology200917—
+3K073500Active Anterior Cervical Plate SystemSanacor20080—
+3K081567Vertebron SSP Cervical Plating SystemVertebron, Inc.20086—
+3K080690Manta Ray Anterior Cervical Plate SystemTheken Spine, LLC200802
+3K073530Accin Anterior Cervical Plate SystemAccelerated Innovation, LLC20083—
+3K071990Valeo Cervical Plate SystemAmedica Corp.20071—
+3K062110Vertebron SCP Cervical Plate SystemVertebron, Inc.20069—
+3K053053Pacp SystemPioneer Surgical Technology200525—
+3K052072The SC-Acufix Ant-Cer Dynamic Cervical Plate System Single Level PlatesAbbott Spine, Inc.200517—
+3K050892Hallmarktm Anterior Cervical Plate SystemBlackstone Medical, Inc.2005522
+3K050813Abc 2 ScrewAesculap, Inc.2005145—
+3K040017Abc Caudal and Cranial Extension Plate (E-Plate)Aesculap, Inc.200413—
+3K040003Vertebron SCP Cervical Plate SystemVertebron, Inc.200412—
+3K031214Cyclone Anterior Cervical Plate SystemEncore Medical L.P.2003132
+3K022965Blackstone Classic Anterior Cervical PlateBlackstone Medical, Inc.200310—
+3K020620Blackstone Iii Degree Anterior Cervical Plating System (Plate Washer)Blackstone Medical, Inc.20021—
+3K020600Blackstone Iii Anterior Cervical Plating System (Plate Washer)Blackstone Medical, Inc.20020—
+4K261309Palisades™ Buttress Plate SystemBethesda Medical Devices, LLC20260—
+4K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+4K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+4K253213SAGI Cervical Cage SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+4K251940PathLoc Lumbar Plate SystemL&K BIOMED Co., Ltd.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—
+4K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+4K243281LOCK-IN Spinal Fixation SystemLock-In USA Corp20240—
+4K243369Cervical Plating SystemLife Spine, Inc.20240—
+4K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+4K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+4K230325GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal SystemGreens Surgicals Pvt., Ltd.20240—
+4K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+4K240935ARENAL Anterior Cervical Plate SystemEffortmed, LLC20240—
+4K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+4K240515uNion® MAX Cervical Plate SystemUlrich Medical USA, Inc.20240—
+4K231694MASADA Modular Spinal Fixation SystemAstura Medical20232—
+4K231839CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd.20232—
+4K230482Swedge™ Pedicle Screw Fixation SystemSpinal Resources, Inc.20231—
+4K220843OAKTREE Anterior Lumbar Plate and Screw SystemOak Tree Engineering, LLC20220—
+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—
+4K220379IMPEACE and IMPEACE-Uni Anterior Cervical Plate SystemMedynus, Inc.20220—
+4K212446NuVasive Anterior Cervical Plate SystemsNu Vasive, Incorporated20211—
+4K212139Admiral ACP SystemSeaSpine Orthopedics Corporation20216—
+4K211903Shoreline Threaded TruProfile® PlateSeaSpine Orthopedics Corporation20217—
+4K212066Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20213—
+4K211205Prase-C Anterior Cervical Plate SystemGbs Commonwealth Co., Ltd.20210—
+4K211932Fixxsure Anterior Lumbar Plate and Screw SystemOak Tree Engineering, LLC20211—
+4K211408CervAlign® Anterior Cervical Plate SystemPioneer Surgical Technology, Inc.20211—
+4K210035ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix…Aegis Spine202110—
+4K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+4K203154KASILOF Cervical Plate SystemKahtnu Surgical, Inc.20200—
+4K201587icotec Anterior Cervical Plate SystemIcotec AG20201—
+4K202227Artus™ cervical plate systemUlrich GmbH & Co. KG20200—
+4K191243HEDRON Cervical SpacersGlobus Medical, Inc.201936—
+4K191500NuVasive® ACP SystemNu Vasive, Incorporated20194—
+4K192076Binary® Anterior Cervical Plate SystemGenesys Spine20190—
+4K190885Elevation Spine Saber-C SystemElevation Spine201925—
+4K191835CREO Stabilization System, Navigation Instruments, ExcelsiusGPS InstrumentsGlobus Medical, Inc.20192—
+4K190376PASS LP Spinal SystemMedicrea International SA201915
+4K183409Athena II Cervical Plate SystemMedyssey USA, Inc.20191—
+4K190053SECULOK™ ACP SystemU&I Corporation20191—
+4K182473PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System, OZARK Cervical Plate…K2m, Inc.20184—
+4K182055SECULOK™ ACP SystemU&I Corporation20182—
+4K180022Athena Cervical Plate SystemMedyssey USA, Inc.20182—
+4K181139OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20188—
+4K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+4K180210CREO® Stabilization SystemGlobus Medical, Inc.201888—
+4K173521SeaSpine Cabo ACP (Anterior Cervical Plate) SystemSeaSpine Orthopedics Corporation201815—
+4K173115COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and…Globus Medical, Inc.201783—
+4K172585Liberty Anterior Cervical PlateValorus Spine20170—
+4K172086Matira™ Anterior Cervical SystemKalitec Direct, LLC20170—
+4K163104Terrace™ Anterior Cervical Plate SystemCorelink, LLC201718—
+4K171112Trifore (tm) Cervical Plating SystemNeurostructures, Inc.20171—
+4K152022SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION®…Globus Medical, Inc.2017149—
+4K163061Altus Spine Cervical Plate SystemAltus Partners, LLC20171—