510(k) Report

Devices descending from K042317

63 later devices reach Cervical Plate through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K070681Next Generation Anterior Cervical Plating SystemAlphatec Spine, Inc.2007621
+2K112533Zavation Cervical Plate SystemZavation, LLC201126—
+2K102820Appliance, Fixation, Spinal Intervertebral BodyAlphatec Spine, Inc.2010382
+3K200995Insignia™ Anterior Cervical Plate SystemAlphatec Spine, Inc.2020729
+3K181244Zavation Cervical Plate SystemZavation Medical Products, LLC20187—
+3K180537Zavation Buttress Plate SystemZavation Medical Products, LLC20180—
+3K173306EZ PlateZavation Medical Products, LLC20180—
+3K163104Terrace™ Anterior Cervical Plate SystemCorelink, LLC201718—
+3K152193Renovis Anterior Cervical Plate SystemRenovis Surgical Technologies, Inc.20154—
+3K150666uNion Cervical Plate SystemUlrich Medical USA201531
+3K130030Zavation Cervical Plate SystemZavation, LLC201315—
+3K111132Genesys Spine Anterior Cervical Plate SystemGenesys Spine201141
+3K103137Venus Anterior Cervical PlateVerticor, Ltd.20115—
+4K240515uNion® MAX Cervical Plate SystemUlrich Medical USA, Inc.20240—
+4K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue®…Lesspine Innovations20230—
+4K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+4K221053Magnes-C Anterior Cervical Plate SystemFellowship of Orthopaedic Researchers, Inc.20230—
+4K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+4K213443Insignia™ Anterior Cervical Plate SystemAlphatec Spine, Inc.20216—
+4K202227Artus™ cervical plate systemUlrich GmbH & Co. KG20200—
+4K200927Transept Cervical Plate SystemNeurostructures, Inc.20200—
+4K193494Origin™ Anterior Cervical Plate SystemOrthopaedic & Spine Development20200—
+4K200170SpineNet SSP SystemSpinenet, LLC20200—
+4K190016Lateral Plate SystemCorelink, LLC201915—
+4K181549Curiteva Midline Anterior Cervical Plate System (or Curiteva Anterior Cervical Plate…Curiteva, LLC20180—
+4K172104Ozark (tm) Cervical Plate SystemK2m, Inc.20175—
+4K152455Amendia Cervical Plate SystemAmendia, Inc.20151—
+4K133245Genesys Spine Anterior Cervical Plate II SystemGenesys Spine201411
+4K131512Katia SystemShanghai Sanyou Medical Co, Ltd.20131—
+5K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+5K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+5K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+5K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+5K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+5K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+5K231593Sapphire X3 Anterior Cervical Plate SystemSpinal Elements, Inc.20230—
+5K203065Lumbar Spine Truss System Plating Solution (LSTS-PS)4Web, Inc.20219—
+5K202192STRUXXURE®-L and STRUXXURE®-A Plate SystemNexxt Spine, LLC20200—
+5K192076Binary® Anterior Cervical Plate SystemGenesys Spine20190—
+5K182473PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System, OZARK Cervical Plate…K2m, Inc.20184—
+5K163366Shanghai Sanyou CARMEN Cervical Fusion SystemShanghai Sanyou Medical Co, Ltd.20170—
+6K253201Lumbar Spine Truss System - Plating Solution (LSTS-PS)4Web, Inc.20260—
+6K253545Vulcan Spinal SystemK2m, Inc.20260—
+6K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.20250—
+6K250769Dakota LP SystemPrecision Spine, Inc.20250—
+6K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+6K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+6K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+6K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+6K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+6K231739Cervical Spine Truss System (CSTS)4Web Medical, Inc.20232—
+6K223362Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device4Web Medical, Inc.20233—
+6K221728Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran™ Anterior…Stryker Corporation20221—
+6K212527Cervical Spine Truss System Plating Solution (CSTS-PS)4Web Medical, Inc.20220—
+7K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+7K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—
+7K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+7K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+7K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+7K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+7K233966Anterior Spine Truss System-Stand Alone (ASTS-SA)4Web Medical, Inc.20241—
+7K230424Omnia Medical Coupler-A™ Anterior Lumbar Plate System; Omnia Medical Coupler-L™ Lateral…Omnia Medical, LLC20230—
+8K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—