510(k) Report

Devices descending from K000536

297 later devices reach Synthes Anterior CSLP System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192494NexGen Anterior Cervical Plate SystemPrecision Spine20190—
+1K181190Pinehurst Anterior Cervical Plate SystemSignature Orthopaedics Pty, Ltd.20190—
+1K181471ACCUFUSE Cervical SystemAbsolute Advantage Medical, LLC20180—
+1K181139OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20188—
+1K170342Ocata Anterior Cervical SystemKalitec Direct, LLC20171—
+1K160702ZION Anterior Cervical Fixation SystemAstura Medical20163—
+1K160522White Pearl Preferred Angle Anterior Cervical PlateOsseus Fusion Systems, LLC20160—
+1K151553Anterior Cervical Plate SystemOsteomed Implantes, Ltda201611—
+1K150983Pyrenees Cervical Plate SystemK2m20157—
+1K150184Dymaxeon Spine SystemBack 2 Basics Direct, LLC201541
+1K143683APEX-DL Spine SystemSpinecraft, LLC20153—
+1K150417Astra Spine SystemSpinecraft, LLC201521—
+1K142237Aviator Anterior Cervical Plate (ACP) SystemStryker Corporation20159—
+1K141253New Era Orthopaedics Polyscrew Pedicle Screw SystemNew Era Orthopaedics, LLC201511
+1K133245Genesys Spine Anterior Cervical Plate II SystemGenesys Spine201411
+1K131521Velox Anterior Cervical Plate SystemSpinecraft, LLC20130—
+1K132994Anodyne Anterior Cervical Plate SystemCorelink, LLC20131—
+1K131025Archon Anterior Cervical Plate SystemNuvasive, Inc.201397—
+1K131810Osseus Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLC201314—
+1K112861Sintea Plustek Anterior Cervical Plate SystemSintea Plustek, LLC20120—
+1K111132Genesys Spine Anterior Cervical Plate SystemGenesys Spine201141
+1K111370Odalys Pedicle Screw SystemKalitec Direct, LLC20111—
+1K111135Pyrenees Cervical Plate System (Translational Plates)K2m, Inc.20111—
+1K103137Venus Anterior Cervical PlateVerticor, Ltd.20115—
+1K103070GPS TM, G Surgical Anterior Cervical Plate System +G Surgical Co., Ltd.20110—
+1K101682S 100 Pedicle Screw SystemRenovis Surgical Technologies, LLC20108—
+1K100265Diamond Anterior Cervical Plate SystemAmendia, Inc.201034—
+1K100215Archimed Remedy Cervical PlateArchimed, Inc.20100—
+1K092474Pyrenees Cervical Plate System, Semi-Constrained ScrewsK2m, Inc.20108—
+1K083020Stryker Spine Reflex Translational Anterior Cervical Plating SystemStryker Corp.20093—
+1K083562Stryker Spine Nulock Anterior Cervical Plating SystemStryker Corp.200916—
+1K083338Cardiff Anterior Cervical Plate SystemSeaspine, Inc.200916—
+1K071990Valeo Cervical Plate SystemAmedica Corp.20071—
+1K070681Next Generation Anterior Cervical Plating SystemAlphatec Spine, Inc.2007621
+1K063430Zero Profile Anterior Cervical Plate (Acp) SystemStryker Spine20072—
+1K062310Reflex Hybrid Acp SystemStryker Spine2006222
+1K061147Opteryx Anterior Cervical Plate SystemInnovasis, Inc.200611
+1K051815Modification to Vertebron SCP Cervical Plate SystemVertebron, Inc.200510—
+1K043066Pioneer Anterior Cervical Plate SystemPioneer Surgical Technology200527—
+1K041989Sintea Biotech Anterior Plate System, Model Acp.XX.T5.XSintea Biotech, Inc.20041—
+2K250446Frida™ Anterior Cervical Plate SystemSpineup, Inc.20250—
+2K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+2K240592Wolff's Law Anterior Cervical Plate SystemSpinal Simplicity, LLC20240—
+2K240484MSFX Mikron Cervical Anterior Plate SystemMikron Makina Sanayi VE Ticaret Ltd. Sti.20240—
+2K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+2K231694MASADA Modular Spinal Fixation SystemAstura Medical20232—
+2K231636LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20232—
+2K231145Axis Anterior Cervical Plate SystemSouthern Medical (Pty), Ltd.20230—
+2K230245LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20233—
+2K223273ASTRA Spine SystemSpinecraft, LLC20228—
+2K221728Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran™ Anterior…Stryker Corporation20221—
+2K212527Cervical Spine Truss System Plating Solution (CSTS-PS)4Web Medical, Inc.20220—
+2K213456Xenco Medical Multilevel CerviKitXenco Medical, LLC20210—
+2K212446NuVasive Anterior Cervical Plate SystemsNu Vasive, Incorporated20211—
+2K210424Quantum Anterior Cervical PlateNvision Biomedical Technologies, Inc.20214—
+2K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+2K211323ASTRA Spine SystemSpinecraft, LLC202112—
+2K210325APOLLO Anterior Cervical Plate (ACP) SystemAurora Spine, Inc.20210—
+2K202972Anterior Cervical Plate SystemNutech Spine and Biologics20200—
+2K201568Calvary Spine Pedicle Screw SystemCalvary Spine, LLC20200—
+2K192930Dymaxeon Spine SystemBack 2 Basics Direct, LLC20201—
+2K192049Oryx Cervical Plate SystemInnovasis, Inc.201901
+2K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+2K192076Binary® Anterior Cervical Plate SystemGenesys Spine20190—
+2K190227Boomerang™ Anterior Cervical Plate SystemChoicespine, LP20194—
+2K180772Met One Czar Anterior Cervical Plate SystemMet One Technologies20180—
+2K180754C-Zero Pedicle Screw System, Freedom Pedicle Screw SystemSignature Orthopaedics Pty, Ltd.20180—
+2K171797TRYPTIK2 C-Plate Anterior Cervical Plate SystemSpineart20180—
+2K172585Liberty Anterior Cervical PlateValorus Spine20170—
+2K172086Matira™ Anterior Cervical SystemKalitec Direct, LLC20170—
+2K170989Dymaxeon Spine SystemBack 2 Basics Direct, LLC20172—
+2K162786PASS LP Spinal SystemMedicrea International SA20176—
+2K162764Jazz Frame SystemImplanet, S.A.20176—
+2K162664Pyrenees Cervical Plate SystemK2m, Inc.20165—
+2K161442NuVasive® CoRoent® Small Interlock™ SystemNu Vasive, Incorporated201694—
+2K161524Tangis Anterior Cervical PlateNvision Biomedical Technologies, LLC20168—
+2K152281Pyrenees Cervical Plate SystemK2m20156—
+2K152098ODALYS Pedicle Screw SystemKisco International20150—
+2K152015Pyrenees Cervical Plate SystemK2m, Inc.20150—
+2K150759Hyper-C Anterior Cervical Plate SystemDegen Medical20154—
+2K150700ACP 1 Anterior Cervical Plating SystemStryker Corporation20150—
+2K142212Pyrenees Cervical Plate SystemK2m, Inc.20150—
+2K150647Polyscrew Pedicle Screw SystemNew Era Orthopedics, LLC201501
+2K132310ASCOTBackroads Consulting, Inc.20130—
+2K131512Katia SystemShanghai Sanyou Medical Co, Ltd.20131—
+2K112206Cardiff Anterior Cervical Plate SystemSeaspine, Inc.201215—
+2K113329K2M, Pyrenees Cervical Plate SystemK2m, Inc.201228—
+2K112533Zavation Cervical Plate SystemZavation, LLC201126—
+2K102820Appliance, Fixation, Spinal Intervertebral BodyAlphatec Spine, Inc.2010382
+2K101848Sapphire Anterior Cervical Plate SystemSpinal Elements, Inc.20102—
+2K100708Pioneer Anterior Cervical Plate Model 24-SeriesPioneer Surgical Technology201012—
+2K083663PACPPioneer Surgical Technology200917—
+2K082037Seeplate Cervical Plate SystemAmedica Corp.20080—
+2K073500Active Anterior Cervical Plate SystemSanacor20080—
+2K081567Vertebron SSP Cervical Plating SystemVertebron, Inc.20086—
+2K073530Accin Anterior Cervical Plate SystemAccelerated Innovation, LLC20083—
+2K062110Vertebron SCP Cervical Plate SystemVertebron, Inc.20069—
+2K053053Pacp SystemPioneer Surgical Technology200525—
+3K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—
+3K252611aprevo® cervical plating systemCarlsmed, Inc.20253—