510(k) Report

Devices descending from K000742

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K240423TDM Anterior Cervical Plate SystemTdm Co., Ltd.20240—
+1K190666CYGNUS™ Anterior Cervical Plate SystemMiRus, LLC20192—
+1K181190Pinehurst Anterior Cervical Plate SystemSignature Orthopaedics Pty, Ltd.20190—
+1K173099Fortis and Hana Anterior Cervical Plate SystemHuvexel Co., Ltd.20174—
+1K151553Anterior Cervical Plate SystemOsteomed Implantes, Ltda201611—
+1K150700ACP 1 Anterior Cervical Plating SystemStryker Corporation20150—
+1K142237Aviator Anterior Cervical Plate (ACP) SystemStryker Corporation20159—
+1K140361Meta-C Cervical PlateMedacta International20140—
+1K121514Anodyne Anterior Cervical Plate SystemCorelink, LLC201221—
+1K112809Blue Mountain Cervical PlateQualgenix, LLC20122—
+1K083020Stryker Spine Reflex Translational Anterior Cervical Plating SystemStryker Corp.20093—
+1K083562Stryker Spine Nulock Anterior Cervical Plating SystemStryker Corp.200916—
+1K063430Zero Profile Anterior Cervical Plate (Acp) SystemStryker Spine20072—
+1K062310Reflex Hybrid Acp SystemStryker Spine2006222
+1K041989Sintea Biotech Anterior Plate System, Model Acp.XX.T5.XSintea Biotech, Inc.20041—
+1K012881C3 Anterior Cervical Plate SystemSpine Vision, Inc.20014—
+2K240592Wolff's Law Anterior Cervical Plate SystemSpinal Simplicity, LLC20240—
+2K240484MSFX Mikron Cervical Anterior Plate SystemMikron Makina Sanayi VE Ticaret Ltd. Sti.20240—
+2K221728Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran™ Anterior…Stryker Corporation20221—
+2K222572FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, and…Dio Medical Corporation20222—
+2K220441CYGNUS™ MoRe Anterior Cervical Plate SystemMiRus, LLC20221—
+2K220379IMPEACE and IMPEACE-Uni Anterior Cervical Plate SystemMedynus, Inc.20220—
+2K210424Quantum Anterior Cervical PlateNvision Biomedical Technologies, Inc.20214—
+2K210325APOLLO Anterior Cervical Plate (ACP) SystemAurora Spine, Inc.20210—
+2K190227Boomerang™ Anterior Cervical Plate SystemChoicespine, LP20194—
+2K180772Met One Czar Anterior Cervical Plate SystemMet One Technologies20180—
+2K172585Liberty Anterior Cervical PlateValorus Spine20170—
+2K163104Terrace™ Anterior Cervical Plate SystemCorelink, LLC201718—
+2K170342Ocata Anterior Cervical SystemKalitec Direct, LLC20171—
+2K161524Tangis Anterior Cervical PlateNvision Biomedical Technologies, LLC20168—
+2K150759Hyper-C Anterior Cervical Plate SystemDegen Medical20154—
+2K150036Blue Mountain Cervical Plate SystemSpineway20151—
+2K132994Anodyne Anterior Cervical Plate SystemCorelink, LLC20131—
+2K112861Sintea Plustek Anterior Cervical Plate SystemSintea Plustek, LLC20120—
+2K073500Active Anterior Cervical Plate SystemSanacor20080—
+3K252611aprevo® cervical plating systemCarlsmed, Inc.20253—
+3K250446Frida™ Anterior Cervical Plate SystemSpineup, Inc.20250—
+3K243369Cervical Plating SystemLife Spine, Inc.20240—
+3K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+3K241175MiRus MoRe Lumbar Plating SystemMiRus, LLC20240—
+3K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue®…Lesspine Innovations20230—
+3K231460FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System…K&J Consulting Corp.20230—
+3K231145Axis Anterior Cervical Plate SystemSouthern Medical (Pty), Ltd.20230—
+3K230424Omnia Medical Coupler-A™ Anterior Lumbar Plate System; Omnia Medical Coupler-L™ Lateral…Omnia Medical, LLC20230—
+3K213901Cyclops™ Anterior Cervical Plate SystemDegen Medical20220—
+3K202657Javelin Tailor's Bunion Fixation SystemNvision Biomedical Technologies, Inc.20201—
+3K193494Origin™ Anterior Cervical Plate SystemOrthopaedic & Spine Development20200—
+3K191786Cyclops™ Anterior Cervical Plate SystemDegen Medical, Inc.20191—
+3K190016Lateral Plate SystemCorelink, LLC201915—
+3K181549Curiteva Midline Anterior Cervical Plate System (or Curiteva Anterior Cervical Plate…Curiteva, LLC20180—
+3K181562Curiteva Anterior Cervical Plate SystemCuriteva, LLC20180—
+3K173091Boundary Anterior Lumbar Buttress PlateNvision Biomedical Technologies, LLC20170—
+3K172086Matira™ Anterior Cervical SystemKalitec Direct, LLC20170—
+3K163602Kepler I Cervical Plate SystemOrbbo Surgical, LLC20170—
+4K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+4K260570corra™ cervical plating systemCarlsmed, Inc.20261—
+4K260291Vortex5 Tailor's Bunion Correction SystemNvision Biomedical Technologies, Inc.20260—
+4K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+4K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+4K203065Lumbar Spine Truss System Plating Solution (LSTS-PS)4Web, Inc.20219—
+4K202192STRUXXURE®-L and STRUXXURE®-A Plate SystemNexxt Spine, LLC20200—
+5K262149corra® cervical plating systemCarlsmed, Inc.20260—
+5K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—
+5K253201Lumbar Spine Truss System - Plating Solution (LSTS-PS)4Web, Inc.20260—
+5K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.20250—
+5K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+5K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+5K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+5K231739Cervical Spine Truss System (CSTS)4Web Medical, Inc.20232—
+5K223362Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device4Web Medical, Inc.20233—
+5K212527Cervical Spine Truss System Plating Solution (CSTS-PS)4Web Medical, Inc.20220—
+6K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+6K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+6K233966Anterior Spine Truss System-Stand Alone (ASTS-SA)4Web Medical, Inc.20241—
+7K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—