510(k) Report

Devices descending from K030866

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K252611aprevo® cervical plating systemCarlsmed, Inc.20253—
+3K250446Frida™ Anterior Cervical Plate SystemSpineup, Inc.20250—
+3K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+3K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+3K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+3K231145Axis Anterior Cervical Plate SystemSouthern Medical (Pty), Ltd.20230—
+3K223321Omnia Medical Coupler-C Anterior Cervical PlateOmnia Medical, LLC20230—
+3K223719Paeon Anterior Cervical Plate System, Elatus Lumbar Plate SystemAegis Spine, Inc.20233—
+3K220334MONET Anterior Cervical Plate SystemCtl Medical Corporation20220—
+3K221728Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran™ Anterior…Stryker Corporation20221—
+3K220275EMERGE Anterior Cervical Plate SystemEvolution Spine20220—
+3K213456Xenco Medical Multilevel CerviKitXenco Medical, LLC20210—
+3K212446NuVasive Anterior Cervical Plate SystemsNu Vasive, Incorporated20211—
+3K211205Prase-C Anterior Cervical Plate SystemGbs Commonwealth Co., Ltd.20210—
+3K210286Cure 2.0 Anterior Cervical Plate (ACP) SystemMeditech Spine, LLC20210—
+3K202657Javelin Tailor's Bunion Fixation SystemNvision Biomedical Technologies, Inc.20201—
+3K192481AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd.202013—
+3K200995Insignia™ Anterior Cervical Plate SystemAlphatec Spine, Inc.2020729
+3K200224SEA-LINK Anterior Cervical Plate SystemIndius Medical Technologies Pvt., Ltd.20200—
+3K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+3K192494NexGen Anterior Cervical Plate SystemPrecision Spine20190—
+3K190053SECULOK™ ACP SystemU&I Corporation20191—
+3K182055SECULOK™ ACP SystemU&I Corporation20182—
+3K181543Cure™ OPEL-C Plate SystemMeditech Spine, LLC20181—
+3K173128Alamo® CAlliance Partners, LLC20182—
+3K171797TRYPTIK2 C-Plate Anterior Cervical Plate SystemSpineart20180—
+3K173521SeaSpine Cabo ACP (Anterior Cervical Plate) SystemSeaSpine Orthopedics Corporation201815—
+3K173091Boundary Anterior Lumbar Buttress PlateNvision Biomedical Technologies, LLC20170—
+3K173099Fortis and Hana Anterior Cervical Plate SystemHuvexel Co., Ltd.20174—
+3K162664Pyrenees Cervical Plate SystemK2m, Inc.20165—
+3K152282Cam Lock Plating SystemLife Spine, Inc.20151—
+3K142212Pyrenees Cervical Plate SystemK2m, Inc.20150—
+3K142218Coalition AGX Plate and Coalition AGX SpacerGlobus Medical, Inc.2015155—
+3K121852Synthes Zero-P Variable Angle (VA)Synthes Spine Co.Lp201230—
+4K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—
+4K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+4K260570corra™ cervical plating systemCarlsmed, Inc.20261—
+4K260291Vortex5 Tailor's Bunion Correction SystemNvision Biomedical Technologies, Inc.20260—
+4K251940PathLoc Lumbar Plate SystemL&K BIOMED Co., Ltd.20260—
+4K250764SpineLinc Anterior Cervical Implant SystemLincotek Medical20250—
+4K250769Dakota LP SystemPrecision Spine, Inc.20250—
+4K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+4K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+4K241164IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic)202412
+4K231839CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd.20232—
+4K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+4K230424Omnia Medical Coupler-A™ Anterior Lumbar Plate System; Omnia Medical Coupler-L™ Lateral…Omnia Medical, LLC20230—
+4K220843OAKTREE Anterior Lumbar Plate and Screw SystemOak Tree Engineering, LLC20220—
+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—
+4K220147Aspiron S ACP SystemU&I Corporation20220—
+4K213443Insignia™ Anterior Cervical Plate SystemAlphatec Spine, Inc.20216—
+4K213115CHENA-C Spacer SystemKahtnu Surgical, Inc.20210—
+4K212139Admiral ACP SystemSeaSpine Orthopedics Corporation20216—
+4K211903Shoreline Threaded TruProfile® PlateSeaSpine Orthopedics Corporation20217—
+4K211932Fixxsure Anterior Lumbar Plate and Screw SystemOak Tree Engineering, LLC20211—
+4K210035ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix…Aegis Spine202110—
+4K202064Admiral ACP SystemSeaSpine Orthopedics Corporation202014—
+4K200523Biolign® Roto-Loc Cervical Plate SystemElite Surgical Supplies (Pty), Ltd.20200—
+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—
+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—
+4K141005Z-Link CervicalZavation, LLC20144—
+4K131429Reliance Cervical Ibf SystemReliance Medical Systems, LLC201324—
+5K262149corra® cervical plating systemCarlsmed, Inc.20260—
+5K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+5K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.20260—
+5K260660SABER-C SystemElevation Spine20261—
+5K253260ORIO-3D Cage SystemSpineCraft20260—
+5K254182AsterOsteonic Co., Ltd.20260—
+5K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+5K253577IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)Medicrea International S.A.S. (Medtronic)20250—
+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—
+5K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+5K231147Hammerdesis™ Interphalangeal Fusion SystemIntelivation20230—
+5K231840CastleLoc-S Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd.20230—
+5K231460FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System…K&J Consulting Corp.20230—
+5K231841PathLoc SI Joint Fusion SystemL&K BIOMED Co., Ltd.20231—
+5K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+5K223521ZESPIN SI Joint Fusion SystemAegis Spine, Inc.20232—
+5K223190Hive™ Standalone Cervical SystemNanoHive Medical, LLC20225—
+5K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+5K221050ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior…Aegis Spine, Inc.20226—
+5K202266Reliance Cervical IBF SystemReliance Medical Systems, LLC20223—
+5K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+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—
+5K191477AEON-C Stand Alone SystemHuvexel Co., Ltd.201910—
+5K180909REVEL SpacersGlobus Medical, Inc.201837—
+5K181357PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc.201897—
+5K173102Reliance Cervical IBF SystemReliance Medical Systems, LLC201715—