510(k) Report

Devices descending from K042544

107 later devices reach Uniplate Anterior Cervical Plate System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K200170SpineNet SSP SystemSpinenet, LLC20200—
+1K192494NexGen Anterior Cervical Plate SystemPrecision Spine20190—
+1K181471ACCUFUSE Cervical SystemAbsolute Advantage Medical, LLC20180—
+1K171834G Surgical OCT Spinal SystemG Surgical, LLC20170—
+1K171439EAGLE Plus Anterior Cervical Plate System, EAGLE Plus Micro Anterior Cervical Plate…Medos International SARL20170—
+1K162664Pyrenees Cervical Plate SystemK2m, Inc.20165—
+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—
+1K150666uNion Cervical Plate SystemUlrich Medical USA201531
+1K142212Pyrenees Cervical Plate SystemK2m, Inc.20150—
+1K133906C-Jaws Cervical Compressive StapleMedicrea International20141—
+1K131521Velox Anterior Cervical Plate SystemSpinecraft, LLC20130—
+1K132310ASCOTBackroads Consulting, Inc.20130—
+1K132994Anodyne Anterior Cervical Plate SystemCorelink, LLC20131—
+1K132324Skyline Anterior Cervical Plate System, Uniplate Anterior Cervical Plate System…Medos International SARL20133—
+1K130030Zavation Cervical Plate SystemZavation, LLC201315—
+1K123167Depuy Pulse Anterior Cervical in-Line Plate SystemMedos International SARL20120—
+1K121514Anodyne Anterior Cervical Plate SystemCorelink, LLC201221—
+1K112748Slimplicity Solo Anterior Cervical Plate SystemSpinal USA, LLC20120—
+1K100215Archimed Remedy Cervical PlateArchimed, Inc.20100—
+1K100070Uniplate Anterior Cervical Plate SystemDepuy Spine, Inc.201047—
+1K082273Uniplate Anterior Cervical Plate SystemDepuy Spine, Inc.200850—
+1K072703Pioneer Slimfuse Anterior Cervical Plating SystemPioneer Surgical Technology200819—
+1K071667Synthes Vectra-One SystemSynthes Spine2007263
+2K250446Frida™ Anterior Cervical Plate SystemSpineup, Inc.20250—
+2K240515uNion® MAX Cervical Plate SystemUlrich Medical USA, Inc.20240—
+2K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+2K231145Axis Anterior Cervical Plate SystemSouthern Medical (Pty), Ltd.20230—
+2K221053Magnes-C Anterior Cervical Plate SystemFellowship of Orthopaedic Researchers, Inc.20230—
+2K213456Xenco Medical Multilevel CerviKitXenco Medical, LLC20210—
+2K210424Quantum Anterior Cervical PlateNvision Biomedical Technologies, Inc.20214—
+2K210325APOLLO Anterior Cervical Plate (ACP) SystemAurora Spine, Inc.20210—
+2K200301UNiTi ACDF Implant SystemPressio, Inc.20210—
+2K202227Artus™ cervical plate systemUlrich GmbH & Co. KG20200—
+2K200927Transept Cervical Plate SystemNeurostructures, Inc.20200—
+2K191584FORTICO Anterior Cervical Fixation SystemCamber Spine Technologies, LLC20192—
+2K190170MVP Cervical Plate SystemGS Medical Co., Ltd.20190—
+2K182473PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System, OZARK Cervical Plate…K2m, Inc.20184—
+2K181549Curiteva Midline Anterior Cervical Plate System (or Curiteva Anterior Cervical Plate…Curiteva, LLC20180—
+2K172585Liberty Anterior Cervical PlateValorus Spine20170—
+2K172104Ozark (tm) Cervical Plate SystemK2m, Inc.20175—
+2K163104Terrace™ Anterior Cervical Plate SystemCorelink, LLC201718—
+2K162194MEDICREA INTERNATIONAL Anterior Cervical Locking Plate SystemMedicrea International SA20160—
+2K161524Tangis Anterior Cervical PlateNvision Biomedical Technologies, LLC20168—
+2K152239Zero-P Natural Plate SystemSynthes (Usa), LLC20150—
+2K152455Amendia Cervical Plate SystemAmendia, Inc.20151—
+2K152015Pyrenees Cervical Plate SystemK2m, Inc.20150—
+2K143576Exactech AmbassadorExactech, Inc.201571
+2K112724Depuy Pulse Anterior Cerical Plate SystemMedos International SARL20112—
+2K100708Pioneer Anterior Cervical Plate Model 24-SeriesPioneer Surgical Technology201012—
+3K252611aprevo® cervical plating systemCarlsmed, Inc.20253—
+3K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+3K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+3K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+3K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+3K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue®…Lesspine Innovations20230—
+3K231593Sapphire X3 Anterior Cervical Plate SystemSpinal Elements, Inc.20230—
+3K221728Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran™ Anterior…Stryker Corporation20221—
+3K211205Prase-C Anterior Cervical Plate SystemGbs Commonwealth Co., Ltd.20210—
+3K202657Javelin Tailor's Bunion Fixation SystemNvision Biomedical Technologies, Inc.20201—
+3K193494Origin™ Anterior Cervical Plate SystemOrthopaedic & Spine Development20200—
+3K190016Lateral Plate SystemCorelink, LLC201915—
+3K190227Boomerang™ Anterior Cervical Plate SystemChoicespine, LP20194—
+3K173867Axis Anterior Cervical Plate SystemAxis Orthopaedics20181—
+3K173091Boundary Anterior Lumbar Buttress PlateNvision Biomedical Technologies, LLC20170—
+3K130427Pioneer Aspect Anterior Cervical Plate SystemPioneer Surgical Technology, Inc.20135—
+3K111528Pioneer Aspect Anterior Cervical Plate Model 24-SeriesPioneer Surgical Technology, Inc.201111—
+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—
+4K253545Vulcan Spinal SystemK2m, Inc.20260—
+4K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+4K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+4K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+4K243369Cervical Plating SystemLife Spine, Inc.20240—
+4K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+4K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+4K230424Omnia Medical Coupler-A™ Anterior Lumbar Plate System; Omnia Medical Coupler-L™ Lateral…Omnia Medical, LLC20230—
+4K203065Lumbar Spine Truss System Plating Solution (LSTS-PS)4Web, Inc.20219—
+4K203154KASILOF Cervical Plate SystemKahtnu Surgical, Inc.20200—
+4K202192STRUXXURE®-L and STRUXXURE®-A Plate SystemNexxt Spine, LLC20200—
+4K183060CervAlign™ Anterior Cervical Plate SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)201921
+4K133245Genesys Spine Anterior Cervical Plate II SystemGenesys Spine201411
+4K121658Orthofix Acp (Anterior Cervical Plate System)Orthofix, Inc.20124—
+5K262149corra® cervical plating systemCarlsmed, 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—
+5K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+5K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+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—
+5K211408CervAlign® Anterior Cervical Plate SystemPioneer Surgical Technology, Inc.20211—
+5K191786Cyclops™ Anterior Cervical Plate SystemDegen Medical, Inc.20191—
+5K192076Binary® Anterior Cervical Plate SystemGenesys Spine20190—
+5K130825Azure Anterior Cervical Plate SystemOrthofix, Inc.201311
+6K261809Interwedge® Standalone LateralFoundation Surgical Group20260—