510(k) Report

Devices descending from K030327

368 later devices reach Zephir Anterior Cervical 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—
+1K141599Divergence Anterior Cervical Fusion SystemMedtronic Sofamor Danek USA, Inc.201516—
+1K141632Zevo (TM) Anterior Cervical Plate SystemMedtronic Sofamor Danek USA, Inc.2014181
+1K140417Divergence Mini-Plate Anterior Cervical Fusion SystemMedtronic Sofamor Danek, Inc.201411—
+1K132653Neoplate Spine Anterior Fixation SystemNeoortho Productos Orthopedicos S/A20140—
+1K122037Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion System Peek Prevail…Medtronic Sofamor Danek, Inc.2013281—
+1K121078Van Gogh Anterior Cervical Plate SystemAccel Spine20120—
+1K112809Blue Mountain Cervical PlateQualgenix, LLC20122—
+1K113509Lexus Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.201219—
+1K100215Archimed Remedy Cervical PlateArchimed, Inc.20100—
+1K092474Pyrenees Cervical Plate System, Semi-Constrained ScrewsK2m, Inc.20108—
+1K063100Atlantis Anterior Cervical Plate System, Translational PlateMedtronic Sofamor Danek, Inc.2007503
+1K061002Maxima Anterior Cervical Plate SystemU&I Corp.200644—
+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—
+2K212358Romero Cervical CageSpineup, Inc.20226—
+2K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+2K192314RESONATE Anterior Cervical Plate SystemGlobus Medical, Inc.20193—
+2K191584FORTICO Anterior Cervical Fixation SystemCamber Spine Technologies, LLC20192—
+2K1824894CIS® Pinehurst Anterior Cervical Plate systemSolco Biomedical Co., Ltd.20191—
+2K172328SOVEREIGN™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201730—
+2K171689ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2017109—
+2K171107CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal SystemMedtronic Sofamor Danek USA, Inc.20178—
+2K161641LOSPA IS ACP SystemCorentec Co., Ltd.20170—
+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—
+2K150135DIVERGENCE-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc.2015228—
+2K142559ELEVATE Spinal SystemMedtronic Sofamor Danek USA, Inc.2015130—
+2K150036Blue Mountain Cervical Plate SystemSpineway20151—
+2K142212Pyrenees Cervical Plate SystemK2m, Inc.20150—
+2K143279LnK Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.20155—
+2K142450DIVERGENCE Anterior Cervical Fusion SystemMedtronic Sofamor Danek USA, Inc.20146—
+2K140234Aspiron Acp SystemU&I Corp.20146—
+2K133205Capstone PTC Spinal System, Clydesdale PTC Spinal SystemMedtronic Sofamor Danek USA, Inc.2014124—
+2K133645Perimeter C Spinal System, Capstone Spinal System, Capstone L Spinal System, Perimeter…Medtronic Sofamor Danek USA, Inc.20146—
+2K131200Aspiron Acp SystemU&I Corporation20137—
+2K121862Rex Anterior Cervical Plate SystemDio Medical Co., Ltd.20127—
+2K121049Unify Dynamic Anterior Cervical Plate SystemGlobus Medical, Inc.201210—
+2K102265LDR Spine Usa C-Plate, TL Anterior Cervical Plate SystemLdr Spine USA20107—
+2K081038Atlantis Anterior Cervical Plate SystemMedtronic Sofamor Danek2008353
+3K261408SABER-XA SystemElevation Spine20260—
+3K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+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—
+3K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+3K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+3K241992Catalyft™ LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.20240—
+3K241164IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic)202412
+3K231251FlexWing Anterior Cervical Plate SystemJeil Medical Corporation20242—
+3K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—
+3K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+3K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+3K230026SqualeImplanet, S.A.20230—
+3K223321Omnia Medical Coupler-C Anterior Cervical PlateOmnia Medical, LLC20230—
+3K223719Paeon Anterior Cervical Plate System, Elatus Lumbar Plate SystemAegis Spine, Inc.20233—
+3K223153Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.20220—
+3K222572FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, and…Dio Medical Corporation20222—
+3K214010Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA202249—
+3K212653Catalyft LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.202127
+3K211769OneLIF Intervertebral Body Replacement SystemNovapproach Spine202112
+3K211205Prase-C Anterior Cervical Plate SystemGbs Commonwealth Co., Ltd.20210—
+3K210425Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.2021561
+3K201267Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek202079—
+3K191788CAPSTONE Spinal System, CLYDESDALE PTC Spinal System, CRESCENT Spinal System, CRESCENT…Medtronic Sofamor Danek USA, Inc.20200—
+3K191066CD Horizon™ Astute™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201921—
+3K190959ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2019108—
+3K190165Capstone Control™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20196—
+3K190425CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.201913—
+3K183073SMG Anterior Cervical Plate SystemSapphire Medical Group20190—
+3K190053SECULOK™ ACP SystemU&I Corporation20191—
+3K181190Pinehurst Anterior Cervical Plate SystemSignature Orthopaedics Pty, Ltd.20190—
+3K181846ASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical Plate System, VIP…Globus Medical, Inc.20184—
+3K182055SECULOK™ ACP SystemU&I Corporation20182—
+3K173189Lumfuse TPPrecifit Medical, Ltd.20180—
+3K180071STYLO Interbody Fusion DeviceLegend Spine Technologies20180—
+3K173099Fortis and Hana Anterior Cervical Plate SystemHuvexel Co., Ltd.20174—
+3K172083Idys™ ALIF SystemClariance, Sas20177—
+3K163366Shanghai Sanyou CARMEN Cervical Fusion SystemShanghai Sanyou Medical Co, Ltd.20170—
+3K172199ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT…Medtronic Sofamor Danek20176—
+3K172104Ozark (tm) Cervical Plate SystemK2m, Inc.20175—
+3K170851Anterior Spine Truss System (STS) Interbody Fusion Device4Web, Inc.20175—
+3K162212Divergence-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc.201757—
+3K163581Navigated ELEVATE Inserter, Navigated Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.2017103—
+3K163602Kepler I Cervical Plate SystemOrbbo Surgical, LLC20170—
+3K162680SOVEREIGN® Spinal SystemMedtronic Sofamor Danek USA, Inc.201631—
+3K153526Pyrenees Cervical Plate SystemK2m20166—
+3K153438PERIMETER C (Titanium) Spinal SystemMedtronic Sofamor Danek USA, Inc.20160—
+3K152277PIVOX (tm) Oblique Lateral Spinal SystemMedtronic Sofamor Danek USA, Inc.2015190—
+3K142101Abacus (TM) Spacer SystemSpine Wave, Inc.20140—
+3K140361Meta-C Cervical PlateMedacta International20140—
+3K133567Unify (R) Dynamic Anterior Cervical Plate SystemGlobus Medical, Inc.20145—
+3K132366Spinal Intervertebral Body Fixation OrthosisAccel Spine20130—
+3K131512Katia SystemShanghai Sanyou Medical Co, Ltd.20131—
+3K131520Nexus Anterior Cervical Plate SystemCore-Nexus20130—
+3K130640Atlantis Anterior Cervical Plate SystemMedtronic Sofamor Danek USA, Inc.201332—
+4K260810Anteralign LS coverplateTyber Medical, LLC20260—
+4K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC20260—