510(k) Report

Devices descending from K042922

677 later devices reach Venture Anterior Cervical Plating System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K150135DIVERGENCE-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc.2015228—
+4K142559ELEVATE Spinal SystemMedtronic Sofamor Danek USA, Inc.2015130—
+4K142487Chesapeake Stabilization SystemK2m, Inc.201571
+4K143214SCARLET® AC-T Secured Anterior Cervical CageSpineart20153—
+4K141599Divergence Anterior Cervical Fusion SystemMedtronic Sofamor Danek USA, Inc.201516—
+4K133245Genesys Spine Anterior Cervical Plate II SystemGenesys Spine201411
+4K141314Scarlet AC-T Secured Anterior Cervical Cage and Associated InstrumentationSpineart201438—
+4K140417Divergence Mini-Plate Anterior Cervical Fusion SystemMedtronic Sofamor Danek, Inc.201411—
+4K133205Capstone PTC Spinal System, Clydesdale PTC Spinal SystemMedtronic Sofamor Danek USA, Inc.2014124—
+4K133645Perimeter C Spinal System, Capstone Spinal System, Capstone L Spinal System, Perimeter…Medtronic Sofamor Danek USA, Inc.20146—
+4K132584Perimeter C Spinal SystemMedtronic Sofamor Danek USA, Inc.2013119—
+4K130853Idys (TM) CClariance20132—
+4K131512Katia SystemShanghai Sanyou Medical Co, Ltd.20131—
+4K131449Coalition SpacerGlobus Medical, Inc.2013235—
+4K121852Synthes Zero-P Variable Angle (VA)Synthes Spine Co.Lp201230—
+4K113252Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek2012306—
+4K112388Lanx Cervical SALanx, Inc.201126—
+4K112444Anatomic Peek Cervical Fusion SystemMedtronic Sofamor Danck USA, Inc.2011324—
+4K110442Nanovis Intervertebral Body Fusion SystemNanovis, LLC201110—
+4K111264Cornerstone (R) PSR Cervical Fusion SystemMedtronic Sofamor Danek USA2011331—
+4K102547Coroent Interlock SystemNuvasive, Inc.2011131—
+5K261408SABER-XA SystemElevation Spine20260—
+5K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+5K260660SABER-C SystemElevation Spine20261—
+5K253260ORIO-3D Cage SystemSpineCraft20260—
+5K242303MOD-COrthomod, LLC20260—
+5K254017SWINGO-3D Lumbar Cage SystemImplanet20260—
+5K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+5K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+5K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+5K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.20250—
+5K250560BEE HANGMedical GmbH20250—
+5K252742Navigated InstrumentsTyber Medical, LLC20251—
+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—
+5K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+5K243915FIX-C 3D Ti ACIF SystemJeil Medical Corporation20250—
+5K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+5K241992Catalyft™ LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.20240—
+5K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+5K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—
+5K241396uCerv Flux™-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA, Inc.20240—
+5K240699SCARLET® AC-TiSpineart SA20240—
+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—
+5K230872Halis™ Lumbar Cage System, Lydia™ Anterior Lumbar Fusion System, Dica™ Direction…Shanghai Sanyou Medical Co, Ltd.20231—
+5K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+5K230478Acro Composites Interbody SystemAcro Composites, LLC20230—
+5K231147Hammerdesis™ Interphalangeal Fusion SystemIntelivation20230—
+5K222988neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D CervicalHt Medical D.B.A. Xenix Medical20232—
+5K232150ZSFab Cervical Interbody SystemZsfab, Inc.20234—
+5K230607SPICCA Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+5K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+5K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+5K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+5K222041CYGNUS-C Standalone ACIF SystemGS Medical Co., Ltd.20231—
+5K223494CD Horizon Spinal SystemMedtronic202317—
+5K223153Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.20220—
+5K223190Hive™ Standalone Cervical SystemNanoHive Medical, LLC20225—
+5K222903Tailored-H Cervical Stand Alone SystemBespoke Technologies, LLC20220—
+5K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+5K220696uCerv Flux-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA20221—
+5K212450Keos Anterior Cervical Interbody Fusion Device SystemKeos20220—
+5K214010Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA202249—
+5K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+5K212358Romero Cervical CageSpineup, Inc.20226—
+5K213115CHENA-C Spacer SystemKahtnu Surgical, Inc.20210—
+5K212653Catalyft LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.202127
+5K212562Idys-C ZP 3DTiClariance, SA20211—
+5K211689KEYSTONE PEEK Cage SystemShanghai Sanyou Medical Co, Ltd.20212—
+5K211769OneLIF Intervertebral Body Replacement SystemNovapproach Spine202112
+5K211903Shoreline Threaded TruProfile® PlateSeaSpine Orthopedics Corporation20217—
+5K210521DEXA-C Cervical Interbody SystemAurora Spine, Inc.20210—
+5K210382Blustone Synergy Diamond SA Cervical SystemBlustone Synergy, LLC20210—
+5K211441Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.20219—
+5K210425Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.2021561
+5K203444BEE HA CageNGMedical GmbH20211—
+5K203065Lumbar Spine Truss System Plating Solution (LSTS-PS)4Web, Inc.20219—
+5K203129NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) SystemPrecision Spine, Inc.20210—
+5K202488ZSFab Cervical Interbody SystemZsfab, Inc.20216—
+5K200549Lucero Medical Cervical Cage SystemLucero Medical, LLC20200—
+5K200719NuVasive Navigation.S InstrumentsNu Vasive, Incorporated20204—
+5K203076Mecta-C Stand Alone ExtensionMedacta International S.A.20200—
+5K202065DOLOMITE Anterior Cervical Stabilization SystemAstura Medical, LLC20203—
+5K193000Hexanium® ACIFSpinevision, S.A.S.202014—
+5K201073Seaspine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202017—
+5K202192STRUXXURE®-L and STRUXXURE®-A Plate SystemNexxt Spine, LLC20200—
+5K201769Cavetto [MAX] Cervical Cage SystemNeurostructures, Inc.20200—
+5K201267Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek202079—
+5K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC202025—
+5K191788CAPSTONE Spinal System, CLYDESDALE PTC Spinal System, CRESCENT Spinal System, CRESCENT…Medtronic Sofamor Danek USA, Inc.20200—
+5K192115SABLE Expandable SpacerGlobus Medical, Inc.202037—
+5K193359SureMAX Family of Cervical SpacersAdditive Implants, Inc.202014—
+5K1920444CIS Marlin PEEK ACIF CageSolco Biomedical Co., Ltd.20190—
+5K191477AEON-C Stand Alone SystemHuvexel Co., Ltd.201910—
+5K191822Nano FortiCore, FortiCoreNanovis, LLC20192—
+5K191537eCarbon IBDsBack 2 Basics Direct, LLC20193—
+5K192076Binary® Anterior Cervical Plate SystemGenesys Spine20190—
+5K192018Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic…Titan Spine, Inc.20191024