510(k) Report

Devices descending from K061274

669 later devices reach Venture Anterior Cervical Plate System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K171312FortiCore®Nanovis, LLC20183—
+4K172083Idys™ ALIF SystemClariance, Sas20177—
+4K172199ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT…Medtronic Sofamor Danek20176—
+4K171567IRIX-A Lumbar Integrated Fusion SystemX-Spine Systems, Inc.201701
+4K171140Matrixx SystemNexxt Spine, LLC2017145—
+4K170851Anterior Spine Truss System (STS) Interbody Fusion Device4Web, Inc.20175—
+4K170399Endoskeleton TO Interbody Fusion Device (IBD)Titan Spine, LLC2017105—
+4K170830Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20175—
+4K170961NuVasive CoRoent Small Interlock II SystemNu Vasive, Incorporated201718—
+4K162212Divergence-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc.201757—
+4K163581Navigated ELEVATE Inserter, Navigated Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.2017103—
+4K170055CAPRI Corpectomy Cage SystemK2m201711—
+4K170243LOSPA IS TLIF & DLIF CagesCorentec Co., Ltd.20170—
+4K163364MOJAVE Expandable Interbody SystemK2m201725—
+4K162680SOVEREIGN® Spinal SystemMedtronic Sofamor Danek USA, Inc.201631—
+4K161993Leva® Anterior Interbody SystemSpine Wave, Inc.20160—
+4K161442NuVasive® CoRoent® Small Interlock™ SystemNu Vasive, Incorporated201694—
+4K162264Cascadia Interbody SystemK2m, Inc.2016169—
+4K161485Nanovis Intervertebral Body Fusion System and Forticore (R)Nanovis, LLC20165—
+4K160066Pro-Link® Stand-Alone Cervical Spacer SystemLife Spine, Inc.20163—
+4K152622Alta ACDF SystemBiomet Spine20160—
+4K160874Nanovis Intervertebral Body Fusion System and FortiCore®Nanovis, LLC20164—
+4K143578SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers…Globus Medical, Inc.2016210—
+4K153250Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies201632—
+4K153438PERIMETER C (Titanium) Spinal SystemMedtronic Sofamor Danek USA, Inc.20160—
+4K151939COALITION SpacersGlobus Medical, Inc.2016152—
+4K151481Sahara Stabilization SystemK2m, Inc.20155—
+4K152277PIVOX (tm) Oblique Lateral Spinal SystemMedtronic Sofamor Danek USA, Inc.2015190—
+4K142299CoRoent Small Interlock SystemNu Vasive, Incorporated201499—
+4K142101Abacus (TM) Spacer SystemSpine Wave, Inc.20140—
+4K142450DIVERGENCE Anterior Cervical Fusion SystemMedtronic Sofamor Danek USA, Inc.20146—
+4K140280ForticoreNanovis, LLC20149—
+4K141005Z-Link CervicalZavation, LLC20144—
+4K132894Optio-C Anterior Cervical SystemZimmer Spine, Inc.201424—
+4K131429Reliance Cervical Ibf SystemReliance Medical Systems, LLC201324—
+5K263049SABER-C SystemElevation Spine20260—
+5K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+5K261049Scala® TLSpineart SA20260—
+5K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+5K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+5K260810Anteralign LS coverplateTyber Medical, LLC20260—
+5K260837VersaLift Expandable SystemLife Spine, Inc.20260—
+5K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+5K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC20260—
+5K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine20260—
+5K253583LUX Expandable Lumbar Interbody SystemXenix Medical20260—
+5K253201Lumbar Spine Truss System - Plating Solution (LSTS-PS)4Web, Inc.20260—
+5K252686EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC20251—
+5K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+5K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+5K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+5K251459OneLIF™ Interbody Fusion SystemNovapproach Spine, LLC20250—
+5K250669Adaptix™ Interbody System with Titan nanoLOCK™ Surface TechnologyMedtronic Sofamor Danek USA, Inc.20250—
+5K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+5K250605EVOL® ha – Hyper C Cervical Interbody Fusion SystemCutting Edge Spine, LLC20250—
+5K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+5K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+5K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+5K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+5K241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc.20241—
+5K242734ZSFab Cervical Interbody System; ZSFab Lumbar Interbody SystemZsfab20243—
+5K233947KLIMT™ Expandable Lumbar Interbody Fusion (LIF) Cage SystemCtl Medical Corporation20240—
+5K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+5K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+5K241605Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spinal System…Nanovis, LLC20240—
+5K241846E3D™-C Interbody SystemEvolution Spine20246—
+5K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+5K240715Idys® C ZP 3DTiClariance20240—
+5K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+5K233191TotalTi ACDF by SAGICOSpinal Analytics & Geometrical Implant Co, LLC20230—
+5K232345ATEC Posterior Navigated Disc Prep InstrumentsAlphatec Spine, Inc.20232—
+5K232348RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion SystemMiRus, LLC20231—
+5K231704Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer SystemLife Spine, Inc.20230—
+5K221138Titus Titanium Cervical by SAGICOSagico VA USA, LLC20231—
+5K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+5K231808QUASAR Standalone ACIF SystemGS Medical Co., Ltd.20230—
+5K231735NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody…Nu Vasive, Incorporated20239—
+5K222015Integral Titanium Cervical InterbodyNvision Biomedical Technologies, Inc.20231—
+5K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+5K230329F3D Interbody SystemCorelink, LLC20230—
+5K230026SqualeImplanet, S.A.20230—
+5K230583Tryptik TiSpineart SA20231—
+5K223231Ti-Largo Cervical Interbody SystemFlospine20230—
+5K220296Manta Ray TDF SpacerSeaSpine Orthopedics Corporation20231—
+5K223362Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device4Web Medical, Inc.20233—
+5K223494CD Horizon Spinal SystemMedtronic202317—
+5K223105Tesera-K SC SystemKyocera Medical Technologies, Inc.20225—
+5K222806Kodiak C Spinal Implant SystemMet One Technologies, LLC20221—
+5K223140AEON-C™ Stand Alone SystemDio Medical, Inc.20222—
+5K221578Hexanium ACIFSpinevision, S.A.S.20224—
+5K221162UniVy OsteoVy Cervical IBF SystemVy Spine, LLC20222—
+5K221858ZSFab Lumbar Interbody SystemZsfab, Inc.20224—
+5K221172FOCUS Interbody SystemOc Medical Devices20220—
+5K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+5K221646CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™…Medtronic Sofamor Danek USA, Inc.202220—
+5K220523restor3d TiDAL Lumbar Interbody Fusion DeviceRestor3D20222—
+5K220581Zavation eZspand Interbody SystemZavation Medical Products, LLC20224—
+5K212527Cervical Spine Truss System Plating Solution (CSTS-PS)4Web Medical, Inc.20220—
+5K202266Reliance Cervical IBF SystemReliance Medical Systems, LLC20223—
+5K214011Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal…Medtronic Sofamor Danek USA, Inc.20221—