510(k) Report

Devices descending from K945700

692 later devices reach Synthes (Usa) Anterior Cervical Vertebrae Plate System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K200523Biolign® Roto-Loc Cervical Plate SystemElite Surgical Supplies (Pty), Ltd.20200—
+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—
+3K181543Cure™ OPEL-C Plate SystemMeditech Spine, LLC20181—
+3K171797TRYPTIK2 C-Plate Anterior Cervical Plate SystemSpineart20180—
+3K173091Boundary Anterior Lumbar Buttress PlateNvision Biomedical Technologies, LLC20170—
+3K163366Shanghai Sanyou CARMEN Cervical Fusion SystemShanghai Sanyou Medical Co, Ltd.20170—
+3K170342Ocata Anterior Cervical SystemKalitec Direct, LLC20171—
+3K170654USS SystemSynthes USA Products, LLC201789—
+3K163061Altus Spine Cervical Plate SystemAltus Partners, LLC20171—
+3K162638CETRA Anterior Cervical Plate SystemOrthofix, Inc.20163—
+3K162664Pyrenees Cervical Plate SystemK2m, Inc.20165—
+3K160702ZION Anterior Cervical Fixation SystemAstura Medical20163—
+3K153526Pyrenees Cervical Plate SystemK2m20166—
+3K160522White Pearl Preferred Angle Anterior Cervical PlateOsseus Fusion Systems, LLC20160—
+3K152239Zero-P Natural Plate SystemSynthes (Usa), LLC20150—
+3K152281Pyrenees Cervical Plate SystemK2m20156—
+3K152015Pyrenees Cervical Plate SystemK2m, Inc.20150—
+3K143688Asfora Anterior Cervical Plate SystemMedical Designs, LLC20150—
+3K142212Pyrenees Cervical Plate SystemK2m, Inc.20150—
+3K143065NuVasive ALIF Buttress Plate SystemNu Vasive, Incorporated20151—
+3K142060Transom Anterior Cervical PlateNeurostructures, Inc.201419—
+3K140234Aspiron Acp SystemU&I Corp.20146—
+3K132310ASCOTBackroads Consulting, Inc.20130—
+3K131200Aspiron Acp SystemU&I Corporation20137—
+3K124058Creo Stabilization SystemGlobus Medical, Inc.2013172—
+3K121514Anodyne Anterior Cervical Plate SystemCorelink, LLC201221—
+3K122910Archon Anterior Cervical Plate Syste,Nu Vasive, Incorporated2012101—
+3K121049Unify Dynamic Anterior Cervical Plate SystemGlobus Medical, Inc.201210—
+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
+3K111528Pioneer Aspect Anterior Cervical Plate Model 24-SeriesPioneer Surgical Technology, Inc.201111—
+3K100243Quintex Cervical Plating SystemAesculap Implant Systems, LLC2010101
+3K091396Cardo Medical Anterior Cervical Plate SystemCardo Medical Corp.20092—
+3K081567Vertebron SSP Cervical Plating SystemVertebron, Inc.20086—
+3K080690Manta Ray Anterior Cervical Plate SystemTheken Spine, LLC200802
+3K073530Accin Anterior Cervical Plate SystemAccelerated Innovation, LLC20083—
+3K072703Pioneer Slimfuse Anterior Cervical Plating SystemPioneer Surgical Technology200819—
+3K071990Valeo Cervical Plate SystemAmedica Corp.20071—
+3K062110Vertebron SCP Cervical Plate SystemVertebron, Inc.20069—
+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—
+3K043181Modification to Vertebron SCP Cervical Plate SystemVertebron, Inc.200411—
+3K040017Abc Caudal and Cranial Extension Plate (E-Plate)Aesculap, Inc.200413—
+3K040397Modification to Cyclone Anterior Cervical Plate SystemEncore Medical L.P.2004032
+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—
+4K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+4K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+4K260570corra™ cervical plating systemCarlsmed, Inc.20261—
+4K253213SAGI Cervical Cage SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+4K260291Vortex5 Tailor's Bunion Correction SystemNvision Biomedical Technologies, Inc.20260—
+4K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+4K251940PathLoc Lumbar Plate SystemL&K BIOMED Co., Ltd.20260—
+4K253545Vulcan Spinal SystemK2m, Inc.20260—
+4K250446Frida™ Anterior Cervical Plate SystemSpineup, Inc.20250—
+4K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+4K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+4K243281LOCK-IN Spinal Fixation SystemLock-In USA Corp20240—
+4K230325GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal SystemGreens Surgicals Pvt., Ltd.20240—
+4K231251FlexWing Anterior Cervical Plate SystemJeil Medical Corporation20242—
+4K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+4K240935ARENAL Anterior Cervical Plate SystemEffortmed, LLC20240—
+4K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+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—
+4K221728Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran™ Anterior…Stryker Corporation20221—
+4K213456Xenco Medical Multilevel CerviKitXenco Medical, LLC20210—
+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—
+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—
+4K201587icotec Anterior Cervical Plate SystemIcotec AG20201—
+4K192494NexGen Anterior Cervical Plate SystemPrecision Spine20190—
+4K192314RESONATE Anterior Cervical Plate SystemGlobus Medical, Inc.20193—
+4K191500NuVasive® ACP SystemNu Vasive, Incorporated20194—
+4K191835CREO Stabilization System, Navigation Instruments, ExcelsiusGPS InstrumentsGlobus Medical, Inc.20192—
+4K183084Fuji Cervical Plate SystemAltus Partners, LLC20190—
+4K190376PASS LP Spinal SystemMedicrea International SA201915
+4K183409Athena II Cervical Plate SystemMedyssey USA, Inc.20191—
+4K190053SECULOK™ ACP SystemU&I Corporation20191—
+4K181846ASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical Plate System, VIP…Globus Medical, Inc.20184—
+4K182055SECULOK™ ACP SystemU&I Corporation20182—