510(k) Report

Devices descending from K031702

245 later devices reach Reflex Anterior Cervical Plate System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K060025Slimplicity Anterior Cervical Plate SystemSpinal USA200611—
+1K040844Life Spine Neo Anterior Cervical Plate SystemLife Spine, LLC200477—
+1K040721Assure Anterior Cervical Plate SystemGlobus Medical, Inc.2004178—
+2K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+2K201521Medina Anterior Cervical Plate SystemAlliance Partners, LLC20200—
+2K192314RESONATE Anterior Cervical Plate SystemGlobus Medical, Inc.20193—
+2K181846ASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical Plate System, VIP…Globus Medical, Inc.20184—
+2K160702ZION Anterior Cervical Fixation SystemAstura Medical20163—
+2K160522White Pearl Preferred Angle Anterior Cervical PlateOsseus Fusion Systems, LLC20160—
+2K133567Unify (R) Dynamic Anterior Cervical Plate SystemGlobus Medical, Inc.20145—
+2K121049Unify Dynamic Anterior Cervical Plate SystemGlobus Medical, Inc.201210—
+2K110990Gso ACP1 Anterior Cervical Plate SystemGold Standard Orthopedics, LLC20110—
+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—
+2K070285Life Spine Anterior Cervical Plate SystemLife Spine200757—
+2K062643Kinetic Anterior Cervical PlateLife Spine200653—
+2K062831Modification to Life Spine Neo Anterior Cervical Plate SystemLife Spine200617—
+3K250446Frida™ Anterior Cervical Plate SystemSpineup, Inc.20250—
+3K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+3K231251FlexWing Anterior Cervical Plate SystemJeil Medical Corporation20242—
+3K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+3K220334MONET Anterior Cervical Plate SystemCtl Medical Corporation20220—
+3K213456Xenco Medical Multilevel CerviKitXenco Medical, LLC20210—
+3K200224SEA-LINK Anterior Cervical Plate SystemIndius Medical Technologies Pvt., Ltd.20200—
+3K192494NexGen Anterior Cervical Plate SystemPrecision Spine20190—
+3K191584FORTICO Anterior Cervical Fixation SystemCamber Spine Technologies, LLC20192—
+3K181190Pinehurst Anterior Cervical Plate SystemSignature Orthopaedics Pty, Ltd.20190—
+3K173099Fortis and Hana Anterior Cervical Plate SystemHuvexel Co., Ltd.20174—
+3K152282Cam Lock Plating SystemLife Spine, Inc.20151—
+3K142218Coalition AGX Plate and Coalition AGX SpacerGlobus Medical, Inc.2015155—
+3K130202Iris Anterior Cervical PlateLife Spine, Inc.201321—
+3K103423Mis Anterior Cervical Plating SystemLife Spine20111—
+3K100215Archimed Remedy Cervical PlateArchimed, Inc.20100—
+3K093776Indus Anterior Cervical Plate SystemSpinefrontier, Inc.201016—
+3K073479Kinetic-SL Anterior Cervical Plate SystemLife Spine200852—
+4K252826ARIX Femur Nail SystemJeil Medical Corporation20250—
+4K250764SpineLinc Anterior Cervical Implant SystemLincotek Medical20250—
+4K250769Dakota LP SystemPrecision Spine, Inc.20250—
+4K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+4K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+4K243369Cervical Plating SystemLife Spine, Inc.20240—
+4K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+4K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue®…Lesspine Innovations20230—
+4K222572FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, and…Dio Medical Corporation20222—
+4K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+4K220379IMPEACE and IMPEACE-Uni Anterior Cervical Plate SystemMedynus, Inc.20220—
+4K211205Prase-C Anterior Cervical Plate SystemGbs Commonwealth Co., Ltd.20210—
+4K191243HEDRON Cervical SpacersGlobus Medical, Inc.201936—
+4K190885Elevation Spine Saber-C SystemElevation Spine201925—
+4K173115COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and…Globus Medical, Inc.201783—
+4K163104Terrace™ Anterior Cervical Plate SystemCorelink, LLC201718—
+4K152022SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION®…Globus Medical, Inc.2017149—
+4K152793Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.201629—
+4K121060Spine Frontier Indus Acp SystemSpinefrontier, Inc.2012156
+4K100614Hallmark Anterior Cervcial Plate System, Hallmark Five-Level Cervical PlatesBlackstone Medical, Inc.201051—
+5K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—
+5K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+5K260660SABER-C SystemElevation Spine20261—
+5K253260ORIO-3D Cage SystemSpineCraft20260—
+5K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+5K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—
+5K250540SABER-C SystemElevation Spine20252—
+5K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+5K231147Hammerdesis™ Interphalangeal Fusion SystemIntelivation20230—
+5K231460FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System…K&J Consulting Corp.20230—
+5K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+5K223190Hive™ Standalone Cervical SystemNanoHive Medical, LLC20225—
+5K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+5K2117123° Anterior Cervical Plating System, Reliant Anterior Cervical Plating System, Unity…Orthofix US, LLC20220—
+5K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+5K211903Shoreline Threaded TruProfile® PlateSeaSpine Orthopedics Corporation20217—
+5K210382Blustone Synergy Diamond SA Cervical SystemBlustone Synergy, LLC20210—
+5K203129NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) SystemPrecision Spine, Inc.20210—
+5K203076Mecta-C Stand Alone ExtensionMedacta International S.A.20200—
+5K202065DOLOMITE Anterior Cervical Stabilization SystemAstura Medical, LLC20203—
+5K201073Seaspine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202017—
+5K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC202025—
+5K193494Origin™ Anterior Cervical Plate SystemOrthopaedic & Spine Development20200—
+5K191477AEON-C Stand Alone SystemHuvexel Co., Ltd.201910—
+5K190016Lateral Plate SystemCorelink, LLC201915—
+5K180909REVEL SpacersGlobus Medical, Inc.201837—
+5K181357PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc.201897—
+5K171567IRIX-A Lumbar Integrated Fusion SystemX-Spine Systems, Inc.201701
+5K170830Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20175—
+5K162638CETRA Anterior Cervical Plate SystemOrthofix, Inc.20163—
+5K153526Pyrenees Cervical Plate SystemK2m20166—
+5K142060Transom Anterior Cervical PlateNeurostructures, Inc.201419—
+5K140234Aspiron Acp SystemU&I Corp.20146—
+5K130825Azure Anterior Cervical Plate SystemOrthofix, Inc.201311
+5K122216Reliance Anterior Cervical Plate SystemReliance Medical Systems, LLC20123—
+5K121658Orthofix Acp (Anterior Cervical Plate System)Orthofix, Inc.20124—
+6K263049SABER-C SystemElevation Spine20260—
+6K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+6K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+6K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+6K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+6K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+6K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+6K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—