510(k) Report

Devices descending from K994239

165 later devices reach Zephir Anterior Cervical Plate System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K182885Atlantis™ Anterior Cervical Plate, Divergence™ Anterior Cervical Fusion System, Premier™…Medtronic Sofamor Danek USA, Inc.20198—
+1K150834Atrax Anterior Cervical Plating SystemX-Spine Systems, Inc.20150—
+1K141632Zevo (TM) Anterior Cervical Plate SystemMedtronic Sofamor Danek USA, Inc.2014181
+1K140234Aspiron Acp SystemU&I Corp.20146—
+1K131200Aspiron Acp SystemU&I Corporation20137—
+1K121078Van Gogh Anterior Cervical Plate SystemAccel Spine20120—
+1K112809Blue Mountain Cervical PlateQualgenix, LLC20122—
+1K113509Lexus Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.201219—
+1K092474Pyrenees Cervical Plate System, Semi-Constrained ScrewsK2m, Inc.20108—
+1K083338Cardiff Anterior Cervical Plate SystemSeaspine, Inc.200916—
+1K061002Maxima Anterior Cervical Plate SystemU&I Corp.200644—
+1K061147Opteryx Anterior Cervical Plate SystemInnovasis, Inc.200611
+1K031214Cyclone Anterior Cervical Plate SystemEncore Medical L.P.2003132
+1K030595Blackstone Fusion Anterior Cervical Plating SystemBlackstone Medical, Inc.200366—
+1K022344Trinica Select Anterior Cervical Plate SystemCenterpulse Spine-Tech, Inc.2002431
+1K012184Blackstone Iii Anterior Cervical Plating SystemBlackstone Medical, Inc.200285—
+2K231251FlexWing Anterior Cervical Plate SystemJeil Medical Corporation20242—
+2K231839CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd.20232—
+2K231090Zevo Anterior Cervical Plate SystemMedtronic Sofamor Danek USA, Inc.20231—
+2K223753Cervical Plate SystemDouble Medical Technology, Inc.20230—
+2K2117123° Anterior Cervical Plating System, Reliant Anterior Cervical Plating System, Unity…Orthofix US, LLC20220—
+2K210182PANAMA™ Anterior Cervical Plate (ACP) SystemFlospine20210—
+2K200523Biolign® Roto-Loc Cervical Plate SystemElite Surgical Supplies (Pty), Ltd.20200—
+2K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+2K192049Oryx Cervical Plate SystemInnovasis, Inc.201901
+2K192314RESONATE Anterior Cervical Plate SystemGlobus Medical, Inc.20193—
+2K191584FORTICO Anterior Cervical Fixation SystemCamber Spine Technologies, LLC20192—
+2K190053SECULOK™ ACP SystemU&I Corporation20191—
+2K1824894CIS® Pinehurst Anterior Cervical Plate systemSolco Biomedical Co., Ltd.20191—
+2K182055SECULOK™ ACP SystemU&I Corporation20182—
+2K162638CETRA Anterior Cervical Plate SystemOrthofix, Inc.20163—
+2K152623ATLANTIS Anterior Cervical Plate SystemMedtronic Sofamor Danek USA, Inc.20159—
+2K152281Pyrenees Cervical Plate SystemK2m20156—
+2K143271CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.201515—
+2K150036Blue Mountain Cervical Plate SystemSpineway20151—
+2K142212Pyrenees Cervical Plate SystemK2m, Inc.20150—
+2K143279LnK Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.20155—
+2K142060Transom Anterior Cervical PlateNeurostructures, Inc.201419—
+2K132012Trinica (R) Anterior Cervical Plate System, Trinica (R) Select Anterior Cervical Plate…Zimmer Spine, Inc.201322—
+2K121862Rex Anterior Cervical Plate SystemDio Medical Co., Ltd.20127—
+2K122497Asfora Anterior Cervical Plate System, One Level, 14MM Asfora Anterior Cervical Plate…Medical Design, LLC20121—
+2K112206Cardiff Anterior Cervical Plate SystemSeaspine, Inc.201215—
+2K111796Invizia Anterior Cervical Plate SystemZimmer Spine, Inc.201118—
+2K102265LDR Spine Usa C-Plate, TL Anterior Cervical Plate SystemLdr Spine USA20107—
+2K050892Hallmarktm Anterior Cervical Plate SystemBlackstone Medical, Inc.2005522
+2K040397Modification to Cyclone Anterior Cervical Plate SystemEncore Medical L.P.2004032
+2K040003Vertebron SCP Cervical Plate SystemVertebron, Inc.200412—
+2K022965Blackstone Classic Anterior Cervical PlateBlackstone Medical, Inc.200310—
+2K020620Blackstone Iii Degree Anterior Cervical Plating System (Plate Washer)Blackstone Medical, Inc.20021—
+2K020600Blackstone Iii Anterior Cervical Plating System (Plate Washer)Blackstone Medical, Inc.20020—
+3K252776ARIES Anterior Cervical Plate SystemsZheJiang Decans Medical Devices Co., Ltd.20260—
+3K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.20260—
+3K251940PathLoc Lumbar Plate SystemL&K BIOMED Co., Ltd.20260—
+3K252826ARIX Femur Nail SystemJeil Medical Corporation20250—
+3K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+3K241164IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic)202412
+3K240935ARENAL Anterior Cervical Plate SystemEffortmed, LLC20240—
+3K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+3K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+3K223321Omnia Medical Coupler-C Anterior Cervical PlateOmnia Medical, LLC20230—
+3K223719Paeon Anterior Cervical Plate System, Elatus Lumbar Plate SystemAegis Spine, Inc.20233—
+3K222572FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, and…Dio Medical Corporation20222—
+3K220147Aspiron S ACP SystemU&I Corporation20220—
+3K211205Prase-C Anterior Cervical Plate SystemGbs Commonwealth Co., Ltd.20210—
+3K202064Admiral ACP SystemSeaSpine Orthopedics Corporation202014—
+3K200927Transept Cervical Plate SystemNeurostructures, Inc.20200—
+3K190425CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.201913—
+3K183073SMG Anterior Cervical Plate SystemSapphire Medical Group20190—
+3K181190Pinehurst Anterior Cervical Plate SystemSignature Orthopaedics Pty, Ltd.20190—
+3K173521SeaSpine Cabo ACP (Anterior Cervical Plate) SystemSeaSpine Orthopedics Corporation201815—
+3K173099Fortis and Hana Anterior Cervical Plate SystemHuvexel Co., Ltd.20174—
+3K172585Liberty Anterior Cervical PlateValorus Spine20170—
+3K172104Ozark (tm) Cervical Plate SystemK2m, Inc.20175—
+3K171112Trifore (tm) Cervical Plating SystemNeurostructures, Inc.20171—
+3K163602Kepler I Cervical Plate SystemOrbbo Surgical, LLC20170—
+3K163061Altus Spine Cervical Plate SystemAltus Partners, LLC20171—
+3K161524Tangis Anterior Cervical PlateNvision Biomedical Technologies, LLC20168—
+3K160702ZION Anterior Cervical Fixation SystemAstura Medical20163—
+3K153526Pyrenees Cervical Plate SystemK2m20166—
+3K160522White Pearl Preferred Angle Anterior Cervical PlateOsseus Fusion Systems, LLC20160—
+3K143688Asfora Anterior Cervical Plate SystemMedical Designs, LLC20150—
+3K143626inVizia Anterior Certical Plate System, SC-AcuFix Ant-Cer Dynamic Cervical Plating…Zimmer Spine, Inc.201516—
+3K132366Spinal Intervertebral Body Fixation OrthosisAccel Spine20130—
+3K131520Nexus Anterior Cervical Plate SystemCore-Nexus20130—
+3K130825Azure Anterior Cervical Plate SystemOrthofix, Inc.201311
+3K121658Orthofix Acp (Anterior Cervical Plate System)Orthofix, Inc.20124—
+3K100614Hallmark Anterior Cervcial Plate System, Hallmark Five-Level Cervical PlatesBlackstone Medical, Inc.201051—
+3K091396Cardo Medical Anterior Cervical Plate SystemCardo Medical Corp.20092—
+3K081567Vertebron SSP Cervical Plating SystemVertebron, Inc.20086—
+3K073530Accin Anterior Cervical Plate SystemAccelerated Innovation, LLC20083—
+3K051815Modification to Vertebron SCP Cervical Plate SystemVertebron, Inc.200510—
+3K043181Modification to Vertebron SCP Cervical Plate SystemVertebron, Inc.200411—
+4K253577IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)Medicrea International S.A.S. (Medtronic)20250—
+4K250446Frida™ Anterior Cervical Plate SystemSpineup, Inc.20250—
+4K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+4K240592Wolff's Law Anterior Cervical Plate SystemSpinal Simplicity, LLC20240—
+4K231460FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System…K&J Consulting Corp.20230—
+4K220379IMPEACE and IMPEACE-Uni Anterior Cervical Plate SystemMedynus, Inc.20220—
+4K213456Xenco Medical Multilevel CerviKitXenco Medical, LLC20210—
+4K210424Quantum Anterior Cervical PlateNvision Biomedical Technologies, Inc.20214—