510(k) Report

Devices descending from K013877

257 later devices reach Codman Slim-Loc System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K191786Cyclops™ Anterior Cervical Plate SystemDegen Medical, Inc.20191—
+1K171439EAGLE Plus Anterior Cervical Plate System, EAGLE Plus Micro Anterior Cervical Plate…Medos International SARL20170—
+1K162638CETRA Anterior Cervical Plate SystemOrthofix, Inc.20163—
+1K121658Orthofix Acp (Anterior Cervical Plate System)Orthofix, Inc.20124—
+1K112533Zavation Cervical Plate SystemZavation, LLC201126—
+1K112724Depuy Pulse Anterior Cerical Plate SystemMedos International SARL20112—
+1K102820Appliance, Fixation, Spinal Intervertebral BodyAlphatec Spine, Inc.2010382
+1K052552Hybrid Anterior Cervical Plate SystemDepuy Spine, Inc.2005397
+1K040655Swift Anterior Cervical Plate SystemDepuy Spine, Inc.2004217—
+2K240935ARENAL Anterior Cervical Plate SystemEffortmed, LLC20240—
+2K2117123° Anterior Cervical Plating System, Reliant Anterior Cervical Plating System, Unity…Orthofix US, LLC20220—
+2K213901Cyclops™ Anterior Cervical Plate SystemDegen Medical20220—
+2K200995Insignia™ Anterior Cervical Plate SystemAlphatec Spine, Inc.2020729
+2K181190Pinehurst Anterior Cervical Plate SystemSignature Orthopaedics Pty, Ltd.20190—
+2K181244Zavation Cervical Plate SystemZavation Medical Products, LLC20187—
+2K180537Zavation Buttress Plate SystemZavation Medical Products, LLC20180—
+2K173306EZ PlateZavation Medical Products, LLC20180—
+2K163104Terrace™ Anterior Cervical Plate SystemCorelink, LLC201718—
+2K152193Renovis Anterior Cervical Plate SystemRenovis Surgical Technologies, Inc.20154—
+2K150666uNion Cervical Plate SystemUlrich Medical USA201531
+2K132324Skyline Anterior Cervical Plate System, Uniplate Anterior Cervical Plate System…Medos International SARL20133—
+2K130427Pioneer Aspect Anterior Cervical Plate SystemPioneer Surgical Technology, Inc.20135—
+2K130825Azure Anterior Cervical Plate SystemOrthofix, Inc.201311
+2K130030Zavation Cervical Plate SystemZavation, LLC201315—
+2K123167Depuy Pulse Anterior Cervical in-Line Plate SystemMedos International SARL20120—
+2K111132Genesys Spine Anterior Cervical Plate SystemGenesys Spine201141
+2K103491Skyline Anterior Cervical Plate SystemA Johnson & Johnson Company201134—
+2K103137Venus Anterior Cervical PlateVerticor, Ltd.20115—
+2K100215Archimed Remedy Cervical PlateArchimed, Inc.20100—
+2K080646C-Tek Maxan Anterior Cervical Plate SystemBiomet Spine20081932
+2K072546Swift Plus Anterior Cervical Plate SystemDepuy Spine, Inc.2007195—
+2K043066Pioneer Anterior Cervical Plate SystemPioneer Surgical Technology200527—
+3K252776ARIES Anterior Cervical Plate SystemsZheJiang Decans Medical Devices Co., Ltd.20260—
+3K250446Frida™ Anterior Cervical Plate SystemSpineup, Inc.20250—
+3K240515uNion® MAX Cervical Plate SystemUlrich Medical USA, Inc.20240—
+3K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue®…Lesspine Innovations20230—
+3K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+3K221053Magnes-C Anterior Cervical Plate SystemFellowship of Orthopaedic Researchers, Inc.20230—
+3K222493CODA™ Anterior Cervical Plate SystemPioneer Surgical Technology, Inc.20221—
+3K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+3K220182Aggeris™-CClariance20221—
+3K213456Xenco Medical Multilevel CerviKitXenco Medical, LLC20210—
+3K213443Insignia™ Anterior Cervical Plate SystemAlphatec Spine, Inc.20216—
+3K202227Artus™ cervical plate systemUlrich GmbH & Co. KG20200—
+3K200927Transept Cervical Plate SystemNeurostructures, Inc.20200—
+3K193494Origin™ Anterior Cervical Plate SystemOrthopaedic & Spine Development20200—
+3K200224SEA-LINK Anterior Cervical Plate SystemIndius Medical Technologies Pvt., Ltd.20200—
+3K200170SpineNet SSP SystemSpinenet, LLC20200—
+3K192494NexGen Anterior Cervical Plate SystemPrecision Spine20190—
+3K191584FORTICO Anterior Cervical Fixation SystemCamber Spine Technologies, LLC20192—
+3K190016Lateral Plate SystemCorelink, LLC201915—
+3K183060CervAlign™ Anterior Cervical Plate SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)201921
+3K181549Curiteva Midline Anterior Cervical Plate System (or Curiteva Anterior Cervical Plate…Curiteva, LLC20180—
+3K172104Ozark (tm) Cervical Plate SystemK2m, Inc.20175—
+3K160702ZION Anterior Cervical Fixation SystemAstura Medical20163—
+3K153526Pyrenees Cervical Plate SystemK2m20166—
+3K151553Anterior Cervical Plate SystemOsteomed Implantes, Ltda201611—
+3K152455Amendia Cervical Plate SystemAmendia, Inc.20151—
+3K143028Azure Anterior Cervical Plate SystemOrthofix, Inc.20150—
+3K133518Maxan Anterior Cervical Plate SystemBiomet Spine (Aka Ebi, LLC)2014251
+3K133245Genesys Spine Anterior Cervical Plate II SystemGenesys Spine201411
+3K131521Velox Anterior Cervical Plate SystemSpinecraft, LLC20130—
+3K133475Struxxure Anterior Cervical Plate and ScrewsNexxt Spine, LLC2013132—
+3K131512Katia SystemShanghai Sanyou Medical Co, Ltd.20131—
+3K123578Anterior Cervical Plate SystemWeigao Orthopaedic Device Co., Ltd.20130—
+3K121078Van Gogh Anterior Cervical Plate SystemAccel Spine20120—
+3K112861Sintea Plustek Anterior Cervical Plate SystemSintea Plustek, LLC20120—
+3K100708Pioneer Anterior Cervical Plate Model 24-SeriesPioneer Surgical Technology201012—
+3K083663PACPPioneer Surgical Technology200917—
+3K081038Atlantis Anterior Cervical Plate SystemMedtronic Sofamor Danek2008353
+3K073500Active Anterior Cervical Plate SystemSanacor20080—
+3K053053Pacp SystemPioneer Surgical Technology200525—
+4K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+4K243904Elegance® Anterior Cervical plateClariance202501
+4K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+4K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+4K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+4K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+4K240690STRUXXURE® MCS Anterior Cervical Plate SystemNexxt Spine20244—
+4K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+4K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+4K231593Sapphire X3 Anterior Cervical Plate SystemSpinal Elements, Inc.20230—
+4K230993CODA™ Anterior Cervical Plate SystemPioneer Surgical Technology, Inc D.B.A Resolve Surgical Tech20230—
+4K210424Quantum Anterior Cervical PlateNvision Biomedical Technologies, Inc.20214—
+4K211205Prase-C Anterior Cervical Plate SystemGbs Commonwealth Co., Ltd.20210—
+4K211408CervAlign® Anterior Cervical Plate SystemPioneer Surgical Technology, Inc.20211—
+4K210325APOLLO Anterior Cervical Plate (ACP) SystemAurora Spine, Inc.20210—
+4K203065Lumbar Spine Truss System Plating Solution (LSTS-PS)4Web, Inc.20219—
+4K202192STRUXXURE®-L and STRUXXURE®-A Plate SystemNexxt Spine, LLC20200—
+4K201979Cervical Plate SystemEminent Spine, LLC20201—
+4K201029Sapphire® Spinal System, Sapphire X Anterior Cervical Plate Spinal SystemSpinal Elements, Inc.20201—
+4K192076Binary® Anterior Cervical Plate SystemGenesys Spine20190—
+4K182885Atlantis™ Anterior Cervical Plate, Divergence™ Anterior Cervical Fusion System, Premier™…Medtronic Sofamor Danek USA, Inc.20198—
+4K182473PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System, OZARK Cervical Plate…K2m, Inc.20184—
+4K172585Liberty Anterior Cervical PlateValorus Spine20170—
+4K163366Shanghai Sanyou CARMEN Cervical Fusion SystemShanghai Sanyou Medical Co, Ltd.20170—
+4K162194MEDICREA INTERNATIONAL Anterior Cervical Locking Plate SystemMedicrea International SA20160—
+4K162250FortiBridge Anterior Cervical Plate SystemNanovis Spine, LLC20160—
+4K162664Pyrenees Cervical Plate SystemK2m, Inc.20165—
+4K161524Tangis Anterior Cervical PlateNvision Biomedical Technologies, LLC20168—