510(k) Report

Devices descending from K971730

394 later devices reach Depuy Motech Peak Polyaxial Anterior Cervical Plate System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K201029Sapphire® Spinal System, Sapphire X Anterior Cervical Plate Spinal SystemSpinal Elements, Inc.20201—
+4K200995Insignia™ Anterior Cervical Plate SystemAlphatec Spine, Inc.2020729
+4K191243HEDRON Cervical SpacersGlobus Medical, Inc.201936—
+4K190885Elevation Spine Saber-C SystemElevation Spine201925—
+4K182885Atlantis™ Anterior Cervical Plate, Divergence™ Anterior Cervical Fusion System, Premier™…Medtronic Sofamor Danek USA, Inc.20198—
+4K173306EZ PlateZavation Medical Products, LLC20180—
+4K173115COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and…Globus Medical, Inc.201783—
+4K172585Liberty Anterior Cervical PlateValorus Spine20170—
+4K163104Terrace™ Anterior Cervical Plate SystemCorelink, LLC201718—
+4K152022SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION®…Globus Medical, Inc.2017149—
+4K162638CETRA Anterior Cervical Plate SystemOrthofix, Inc.20163—
+4K162250FortiBridge Anterior Cervical Plate SystemNanovis Spine, LLC20160—
+4K161524Tangis Anterior Cervical PlateNvision Biomedical Technologies, LLC20168—
+4K152793Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.201629—
+4K150700ACP 1 Anterior Cervical Plating SystemStryker Corporation20150—
+4K141632Zevo (TM) Anterior Cervical Plate SystemMedtronic Sofamor Danek USA, Inc.2014181
+4K133245Genesys Spine Anterior Cervical Plate II SystemGenesys Spine201411
+4K141376Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx, Struxxure Anterior…Nexxt Spine, LLC2014106—
+4K140361Meta-C Cervical PlateMedacta International20140—
+4K140742Reliance Anterior Cervical PlateReliance Medical Systems, LLC20142—
+4K131512Katia SystemShanghai Sanyou Medical Co, Ltd.20131—
+4K130640Atlantis Anterior Cervical Plate SystemMedtronic Sofamor Danek USA, Inc.201332—
+4K123167Depuy Pulse Anterior Cervical in-Line Plate SystemMedos International SARL20120—
+4K121658Orthofix Acp (Anterior Cervical Plate System)Orthofix, Inc.20124—
+4K112533Zavation Cervical Plate SystemZavation, LLC201126—
+4K102820Appliance, Fixation, Spinal Intervertebral BodyAlphatec Spine, Inc.2010382
+5K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+5K252776ARIES Anterior Cervical Plate SystemsZheJiang Decans Medical Devices Co., Ltd.20260—
+5K260660SABER-C SystemElevation Spine20261—
+5K253260ORIO-3D Cage SystemSpineCraft20260—
+5K260697VyPlate™ Anterior Cervical Plate SystemVy Spine, LLC20260—
+5K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+5K252611aprevo® cervical plating systemCarlsmed, Inc.20253—
+5K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—
+5K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+5K250540SABER-C SystemElevation Spine20252—
+5K251436Resolve Anterior Cervical Plate SystemPioneer Surgical Technology, Inc.20250—
+5K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+5K240935ARENAL Anterior Cervical Plate SystemEffortmed, LLC20240—
+5K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+5K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue®…Lesspine Innovations20230—
+5K231147Hammerdesis™ Interphalangeal Fusion SystemIntelivation20230—
+5K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+5K231593Sapphire X3 Anterior Cervical Plate SystemSpinal Elements, Inc.20230—
+5K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+5K231460FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System…K&J Consulting Corp.20230—
+5K231090Zevo Anterior Cervical Plate SystemMedtronic Sofamor Danek USA, Inc.20231—
+5K230424Omnia Medical Coupler-A™ Anterior Lumbar Plate System; Omnia Medical Coupler-L™ Lateral…Omnia Medical, LLC20230—
+5K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+5K223753Cervical Plate SystemDouble Medical Technology, Inc.20230—
+5K223190Hive™ Standalone Cervical SystemNanoHive Medical, LLC20225—
+5K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+5K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+5K2117123° Anterior Cervical Plating System, Reliant Anterior Cervical Plating System, Unity…Orthofix US, LLC20220—
+5K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+5K213443Insignia™ Anterior Cervical Plate SystemAlphatec Spine, Inc.20216—
+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—
+5K202657Javelin Tailor's Bunion Fixation SystemNvision Biomedical Technologies, Inc.20201—
+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—
+5K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+5K191477AEON-C Stand Alone SystemHuvexel Co., Ltd.201910—
+5K192076Binary® Anterior Cervical Plate SystemGenesys Spine20190—
+5K190016Lateral Plate SystemCorelink, LLC201915—
+5K1824894CIS® Pinehurst Anterior Cervical Plate systemSolco Biomedical Co., Ltd.20191—
+5K180909REVEL SpacersGlobus Medical, Inc.201837—
+5K181357PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc.201897—
+5K181435ATEC Cervical Spacer SystemAlphatec Spine, Inc.2018100—
+5K181244Zavation Cervical Plate SystemZavation Medical Products, LLC20187—
+5K180537Zavation Buttress Plate SystemZavation Medical Products, LLC20180—
+5K173091Boundary Anterior Lumbar Buttress PlateNvision Biomedical Technologies, LLC20170—
+5K163366Shanghai Sanyou CARMEN Cervical Fusion SystemShanghai Sanyou Medical Co, Ltd.20170—
+5K171567IRIX-A Lumbar Integrated Fusion SystemX-Spine Systems, Inc.201701
+5K170830Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20175—
+5K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+5K152623ATLANTIS Anterior Cervical Plate SystemMedtronic Sofamor Danek USA, Inc.20159—
+5K152193Renovis Anterior Cervical Plate SystemRenovis Surgical Technologies, Inc.20154—
+5K143706FortiBridge Anterior Cervical Plate SystemNanovis Spine, LLC20151—
+5K141599Divergence Anterior Cervical Fusion SystemMedtronic Sofamor Danek USA, Inc.201516—
+5K140417Divergence Mini-Plate Anterior Cervical Fusion SystemMedtronic Sofamor Danek, Inc.201411—
+5K130825Azure Anterior Cervical Plate SystemOrthofix, Inc.201311
+5K130030Zavation Cervical Plate SystemZavation, LLC201315—
+5K111132Genesys Spine Anterior Cervical Plate SystemGenesys Spine201141
+5K103137Venus Anterior Cervical PlateVerticor, Ltd.20115—
+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—
+6K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+6K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+6K260570corra™ cervical plating systemCarlsmed, Inc.20261—
+6K260291Vortex5 Tailor's Bunion Correction SystemNvision Biomedical Technologies, 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—
+6K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—