510(k) Report

Devices descending from K030866

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231251FlexWing Anterior Cervical Plate SystemJeil Medical Corporation20242—
+1K201587icotec Anterior Cervical Plate SystemIcotec AG20201—
+1K200883CarboClear® Cervical Plate SystemCarboFix Orthopedics, Ltd.20200—
+1K192049Oryx Cervical Plate SystemInnovasis, Inc.201901
+1K191500NuVasive® ACP SystemNu Vasive, Incorporated20194—
+1K191786Cyclops™ Anterior Cervical Plate SystemDegen Medical, Inc.20191—
+1K190170MVP Cervical Plate SystemGS Medical Co., Ltd.20190—
+1K190227Boomerang™ Anterior Cervical Plate SystemChoicespine, LP20194—
+1K181190Pinehurst Anterior Cervical Plate SystemSignature Orthopaedics Pty, Ltd.20190—
+1K181562Curiteva Anterior Cervical Plate SystemCuriteva, LLC20180—
+1K173935Mediant Anterior Cervical Plating SystemIntelligent Implant Systems, LLC20180—
+1K173375Anterior Cervical Plate SystemEvolution Spine, LLC20172—
+1K172104Ozark (tm) Cervical Plate SystemK2m, Inc.20175—
+1K170224Spider Cervical Plating SystemX-Spine Systems, Inc.20171—
+1K171112Trifore (tm) Cervical Plating SystemNeurostructures, Inc.20171—
+1K162194MEDICREA INTERNATIONAL Anterior Cervical Locking Plate SystemMedicrea International SA20160—
+1K151553Anterior Cervical Plate SystemOsteomed Implantes, Ltda201611—
+1K152193Renovis Anterior Cervical Plate SystemRenovis Surgical Technologies, Inc.20154—
+1K143688Asfora Anterior Cervical Plate SystemMedical Designs, LLC20150—
+1K141632Zevo (TM) Anterior Cervical Plate SystemMedtronic Sofamor Danek USA, Inc.2014181
+1K141500Optio-C Anterior Cervical SystemZimmer Spine, Inc.20142—
+1K122497Asfora Anterior Cervical Plate System, One Level, 14MM Asfora Anterior Cervical Plate…Medical Design, LLC20121—
+1K122216Reliance Anterior Cervical Plate SystemReliance Medical Systems, LLC20123—
+1K112748Slimplicity Solo Anterior Cervical Plate SystemSpinal USA, LLC20120—
+1K121060Spine Frontier Indus Acp SystemSpinefrontier, Inc.2012156
+1K120515Tempus Cervical Plate SystemNeurostructures, LLC201223—
+1K111796Invizia Anterior Cervical Plate SystemZimmer Spine, Inc.201118—
+1K110990Gso ACP1 Anterior Cervical Plate SystemGold Standard Orthopedics, LLC20110—
+1K103068King Cobra Anterior Cervical PlateEminent Spine20112—
+1K103070GPS TM, G Surgical Anterior Cervical Plate System +G Surgical Co., Ltd.20110—
+1K092695Transcorp Trans-Plate Anterior Cervical Plate SystemTranscorp, Inc.20100—
+1K100215Archimed Remedy Cervical PlateArchimed, Inc.20100—
+1K093776Indus Anterior Cervical Plate SystemSpinefrontier, Inc.201016—
+1K091134Custom Spine Regent Anterior Cervical PlateCustom Spine, Inc.200910—
+1K073500Active Anterior Cervical Plate SystemSanacor20080—
+1K073232Indus Anterior Cervical Plate System, Model IM3XXXSpinefrontier, Inc.200817—
+1K072650Ist Anterior Cervical Plate SystemInnovative Spinal Technologies, Inc.20078—
+1K060025Slimplicity Anterior Cervical Plate SystemSpinal USA200611—
+1K051665Synthes Vectra-T SystemSynthes Spine2005492
+1K050588Verteview Anterior Cervical Plate SystemInnovative Spinal Design, LLC200516—
+1K033951Radix Cervical PlatePisharodi Surgicals, Inc.20041—
+1K040721Assure Anterior Cervical Plate SystemGlobus Medical, Inc.2004178—
+2K252826ARIX Femur Nail SystemJeil Medical Corporation20250—
+2K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+2K243369Cervical Plating SystemLife Spine, Inc.20240—
+2K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+2K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+2K240592Wolff's Law Anterior Cervical Plate SystemSpinal Simplicity, LLC20240—
+2K233215icotec Anterior Cervical Plate SystemIcotec AG20240—
+2K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue®…Lesspine Innovations20230—
+2K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+2K230608SPICCA Stand-Alone Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+2K231090Zevo Anterior Cervical Plate SystemMedtronic Sofamor Danek USA, Inc.20231—
+2K223753Cervical Plate SystemDouble Medical Technology, Inc.20230—
+2K221572VyPlate Anterior Cervical Plate SystemVy Spine, LLC20221—
+2K213901Cyclops™ Anterior Cervical Plate SystemDegen Medical20220—
+2K210424Quantum Anterior Cervical PlateNvision Biomedical Technologies, Inc.20214—
+2K212405EMERGE™ Anterior Cervical Plate SystemEvolution Spine20211—
+2K210325APOLLO Anterior Cervical Plate (ACP) SystemAurora Spine, Inc.20210—
+2K203253NuVasive ACP SystemNu Vasive, Incorporated20202—
+2K201979Cervical Plate SystemEminent Spine, LLC20201—
+2K201521Medina Anterior Cervical Plate SystemAlliance Partners, LLC20200—
+2K200927Transept Cervical Plate SystemNeurostructures, Inc.20200—
+2K201078NuVasive® ACP SystemNu Vasive, Incorporated20203—
+2K193494Origin™ Anterior Cervical Plate SystemOrthopaedic & Spine Development20200—
+2K192314RESONATE Anterior Cervical Plate SystemGlobus Medical, Inc.20193—
+2K191584FORTICO Anterior Cervical Fixation SystemCamber Spine Technologies, LLC20192—
+2K182885Atlantis™ Anterior Cervical Plate, Divergence™ Anterior Cervical Fusion System, Premier™…Medtronic Sofamor Danek USA, Inc.20198—
+2K1824894CIS® Pinehurst Anterior Cervical Plate systemSolco Biomedical Co., Ltd.20191—
+2K182473PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System, OZARK Cervical Plate…K2m, Inc.20184—
+2K181846ASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical Plate System, VIP…Globus Medical, Inc.20184—
+2K172585Liberty Anterior Cervical PlateValorus Spine20170—
+2K161524Tangis Anterior Cervical PlateNvision Biomedical Technologies, LLC20168—
+2K160702ZION Anterior Cervical Fixation SystemAstura Medical20163—
+2K160604Cure™ Anterior Cervical Plate (ACP) SystemMeditech Spine, LLC20163—
+2K153526Pyrenees Cervical Plate SystemK2m20166—
+2K160522White Pearl Preferred Angle Anterior Cervical PlateOsseus Fusion Systems, LLC20160—
+2K153042TRYPTIK2C-plate Anterior Cervical Plate SystemSpineart201617
+2K152239Zero-P Natural Plate SystemSynthes (Usa), LLC20150—
+2K152623ATLANTIS Anterior Cervical Plate SystemMedtronic Sofamor Danek USA, Inc.20159—
+2K143626inVizia Anterior Certical Plate System, SC-AcuFix Ant-Cer Dynamic Cervical Plating…Zimmer Spine, Inc.201516—
+2K142060Transom Anterior Cervical PlateNeurostructures, Inc.201419—
+2K141993Nakoma AcpAlliance Partners, LLC201481
+2K140234Aspiron Acp SystemU&I Corp.20146—
+2K140742Reliance Anterior Cervical PlateReliance Medical Systems, LLC20142—
+2K133567Unify (R) Dynamic Anterior Cervical Plate SystemGlobus Medical, Inc.20145—
+2K131374Tempus (TM) Cervical Plate SystemNeurostructures, LLC201322—
+2K121049Unify Dynamic Anterior Cervical Plate SystemGlobus Medical, Inc.201210—
+2K112068Synthes Zero-P Variable Angle (VA)Synthes Spine Co.Lp2011331
+2K111135Pyrenees Cervical Plate System (Translational Plates)K2m, Inc.20111—
+2K101151Regent Anterior Cervical PlateCustom Spine20100—
+2K092146Xtend Anterior Cervical Plate SystemGlobus Medical, Inc.200911—
+2K081391Vip Anterior Cervical Plate SystemGlobus Medical, Inc.2008171—
+2K070775Modification to: Providence Anterior Cervical Plate SystemGlobus Medical, Inc.2007177—
+2K070335Simplex Cervical Fixation SystemPisharodi Surgicals, Inc.20070—
+3K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+3K252776ARIES Anterior Cervical Plate SystemsZheJiang Decans Medical Devices Co., Ltd.20260—
+3K253213SAGI Cervical Cage SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+3K260697VyPlate™ Anterior Cervical Plate SystemVy Spine, LLC20260—
+3K253545Vulcan Spinal SystemK2m, Inc.20260—