510(k) Report

Devices descending from K042922

677 later devices reach Venture Anterior Cervical Plating 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—
+1K100215Archimed Remedy Cervical PlateArchimed, Inc.20100—
+1K071033T2 XVBR Spinal SystemMedtronic Sofamor Danek200750—
+1K061274Venture Anterior Cervical Plate SystemMedtronic Sofamor Danek2006669—
+2K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+2K191584FORTICO Anterior Cervical Fixation SystemCamber Spine Technologies, LLC20192—
+2K183510T2 STRATOSPHERE Expandable Corpectomy SystemMedtronic Sofamor Danek USA, Inc.201927—
+2K173125T2 STRATOSPHERE™ Expandable Corpectomy SystemMedtronic Sofamor Danek201747—
+2K140234Aspiron Acp SystemU&I Corp.20146—
+2K121862Rex Anterior Cervical Plate SystemDio Medical Co., Ltd.20127—
+2K102820Appliance, Fixation, Spinal Intervertebral BodyAlphatec Spine, Inc.2010382
+2K100976T2 XVBR 1.5 Spinal SystemMedtronic Sofamor Danek USA, Inc.201049—
+2K073285Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek USA, Inc.2008637—
+3K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+3K241164IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic)202412
+3K231251FlexWing Anterior Cervical Plate SystemJeil Medical Corporation20242—
+3K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+3K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+3K222572FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, and…Dio Medical Corporation20222—
+3K210470C-CURVE Interbody Fusion DeviceMedicrea International SA20210—
+3K211205Prase-C Anterior Cervical Plate SystemGbs Commonwealth Co., Ltd.20210—
+3K200995Insignia™ Anterior Cervical Plate SystemAlphatec Spine, Inc.2020729
+3K191066CD Horizon™ Astute™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201921—
+3K191039Navigated T2 STRATOSPHERE Inserters and Navigated TemplatesMedtronic Sofamor Danek USA, Inc.201918—
+3K190053SECULOK™ ACP SystemU&I Corporation20191—
+3K181328T2 STRATOSPHERE™ Expandable Corpectomy SystemMedtronic Sofamor Danek USA, Inc.201828—
+3K182055SECULOK™ ACP SystemU&I Corporation20182—
+3K173099Fortis and Hana Anterior Cervical Plate SystemHuvexel Co., Ltd.20174—
+3K163104Terrace™ Anterior Cervical Plate SystemCorelink, LLC201718—
+3K162531Sterispine CCSafe Orthopaedics20160—
+3K153373CORNERSTONE PSR Cervical Fusion System, PERIMETER C Spinal System, PEEK PREVAIL Cervical…Medtronic Sofamor Danek2016110—
+3K152193Renovis Anterior Cervical Plate SystemRenovis Surgical Technologies, Inc.20154—
+3K142218Coalition AGX Plate and Coalition AGX SpacerGlobus Medical, Inc.2015155—
+3K142940Endoskeleton TCS SystemTitan Spine, LLC20151112
+3K133494Chesapeake Spinal SystemK2m, Inc.2014330—
+3K131888T2 XVBR Spinal System, T2 Altitude Expandable Corpectomy DeviceMedtronic Sofamor Danek, Inc.20130—
+3K132366Spinal Intervertebral Body Fixation OrthosisAccel Spine20130—
+3K131520Nexus Anterior Cervical Plate SystemCore-Nexus20130—
+3K122037Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion System Peek Prevail…Medtronic Sofamor Danek, Inc.2013281—
+3K120275Synthes Acis/Vertebral Spacer CRSynthes (Usa), LLC2012173—
+3K112459Synthes Zero-PSynthes Spine Co.Lp2011277—
+3K111132Genesys Spine Anterior Cervical Plate SystemGenesys Spine201141
+3K112068Synthes Zero-P Variable Angle (VA)Synthes Spine Co.Lp2011331
+3K100967Perimeter C Spinal SystemMedtronic Sofamor Danek USA, Inc.2011121—
+3K103137Venus Anterior Cervical PlateVerticor, Ltd.20115—
+3K102323Cervical Standalone Intervertebral Body Fusion DeviceTheken Spine, LLC201062—
+3K094042Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek2010397—
+3K100214Cornerstone PSR Cervical Interbody Fusion DeviceMedtronic Sofamor Danek2010389—
+4K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+4K253213SAGI Cervical Cage SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+4K253577IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)Medicrea International S.A.S. (Medtronic)20250—
+4K252826ARIX Femur Nail SystemJeil Medical Corporation20250—
+4K250764SpineLinc Anterior Cervical Implant SystemLincotek Medical20250—
+4K250769Dakota LP SystemPrecision Spine, Inc.20250—
+4K250446Frida™ Anterior Cervical Plate SystemSpineup, Inc.20250—
+4K242195Gemini Cervical Fusion Cage SystemZheJiang Decans Medical Devices Co., Ltd.20241—
+4K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue®…Lesspine Innovations20230—
+4K231739Cervical Spine Truss System (CSTS)4Web Medical, Inc.20232—
+4K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+4K231460FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System…K&J Consulting Corp.20230—
+4K220334MONET Anterior Cervical Plate SystemCtl Medical Corporation20220—
+4K221646CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™…Medtronic Sofamor Danek USA, Inc.202220—
+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—
+4K212266FIX-C PEEK Anterior Cervical Interbody SystemJeil Medical Corporation20217—
+4K213443Insignia™ Anterior Cervical Plate SystemAlphatec Spine, Inc.20216—
+4K200458Tailored-C Cervical Interbody Fusion SystemBespoke Technologies20203—
+4K193494Origin™ Anterior Cervical Plate SystemOrthopaedic & Spine Development20200—
+4K192906Mecta-C Stand AloneMedacta International S.A.20201—
+4K192336Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.201917—
+4K192208CORNICE Cervical Spacer SystemLegend Spine Technologies20190—
+4K191243HEDRON Cervical SpacersGlobus Medical, Inc.201936—
+4K190885Elevation Spine Saber-C SystemElevation Spine201925—
+4K191565Endoskeleton TCS Interbody Fusion DeviceTitan Spine, Inc.201901
+4K190016Lateral Plate SystemCorelink, LLC201915—
+4K180909REVEL SpacersGlobus Medical, Inc.201837—
+4K181140Axis Chena Cervical PEEK Spacer SystemAxis Orthopaedics20182—
+4K181229TirboLOX-C Cervical IBFDCaptiva Spine, Inc.20180—
+4K180364HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC2018106—
+4K173722PATRIOT COLONIAL Spacer, SUSTAIN SpacerGlobus Medical, Inc.201894—
+4K172320Neurostructures Cavetto® Cervical Cage SystemNeurostructures, Inc.20183—
+4K172926SeaSpine Vu cPOD, Zuma-C, Complete CervicalSeaSpine Orthopedics Corporation201761—
+4K172185Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20177—
+4K173115COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and…Globus Medical, Inc.201783—
+4K172019Brisbane ALIF Device, Gladstone ALIF DeviceSignature Orthopaedics Pty, Ltd.20170—
+4K172328SOVEREIGN™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201730—
+4K163366Shanghai Sanyou CARMEN Cervical Fusion SystemShanghai Sanyou Medical Co, Ltd.20170—
+4K171689ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2017109—
+4K172065Scarlet AC-TSpineart20172—
+4K171107CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal SystemMedtronic Sofamor Danek USA, Inc.20178—
+4K163422Shanghai Sanyou PEEK Cage SystemShanghai Sanyou Medical Co, Ltd.20173—
+4K170318NeoFuse Ti3D PLIF/TLIF/Cervical InterbodyHt Medical, LLC201749—
+4K152022SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION®…Globus Medical, Inc.2017149—
+4K1624024CIS® Marlin ACIF Cage SystemSolco Biomedical Co., Ltd.20171—
+4K160125Cascadia Interbody SystemK2m2016315—
+4K152793Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.201629—
+4K153122Endoskeleton (r) TCS SystemTitan Spine, LLC20151061
+4K151596Endoskeleton TCS Interbody Fusion DeviceTitan Spine, LLC20151101
+4K151408LOSPA IS Spinal SystemCorentec Co., Ltd.20151—