510(k) Report

Devices descending from K012254

2,058 later devices reach VBR through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K033926Hourglass Vertebral Body SpacerMedtronic Sofamor Danek2004763—
+3K041556Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek20041,002—
+3K040536Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek20041,150—
+3K040422Modification to Verte-StackMedtronic Sofamor Danek20041,002—
+4K261810Vertiwedge® Intraosseous SystemFoundation Surgical Group20260—
+4K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+4K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+4K253158VyBrate™ VBR SystemVy Spine, LLC20260—
+4K253577IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)Medicrea International S.A.S. (Medtronic)20250—
+4K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+4K241992Catalyft™ LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.20240—
+4K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+4K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+4K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+4K232481RIGEL™ 3DR Anterior Cervical Corpectomy SystemMiRus, LLC20230—
+4K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+4K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+4K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+4K230329F3D Interbody SystemCorelink, LLC20230—
+4K223153Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.20220—
+4K221646CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™…Medtronic Sofamor Danek USA, Inc.202220—
+4K221244CD Horizon™ Spinal SystemMedtronic202220—
+4K214010Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA202249—
+4K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+4K210425Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.2021561
+4K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135—
+4K203678CD HORIZON™ Spinal SystemMedtronic Sofamor Danek USA, Inc.202135—
+4K202328CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20200—
+4K201267Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek202079—
+4K200519CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202011—
+4K191788CAPSTONE Spinal System, CLYDESDALE PTC Spinal System, CRESCENT Spinal System, CRESCENT…Medtronic Sofamor Danek USA, Inc.20200—
+4K190426ALTA Anterior Cervical Corpectomy SystemAstura Medical, LLC20193—
+4K191537eCarbon IBDsBack 2 Basics Direct, LLC20193—
+4K191778Omnia Medical VBROmnia Medical, LLC20195—
+4K183249Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved…Stryker Spine20196—
+4K190147COLOSSEUM MeshGlobus Medical, Inc.20190—
+4K190165Capstone Control™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20196—
+4K183197PYRAMESH™ Implant SystemMedtronic Sofamor Danek USA, Inc.20190—
+4K183588Choice Spine Hawkeye Vertebral Body Replacement (VBR) SystemChoicespine20195—
+4K181357PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc.201897—
+4K181591Fixated Asfora BULLET CAGE® (FABC)Medical Designs, LLC20180—
+4K173982FORTIFY Corpectomy SpacersGlobus Medical, Inc.20188—
+4K173893TrabisColigne AG20180—
+4K182119CD HORIZON™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201858—
+4K181261Curiteva Cervical Interbody Fusion SystemCuriteva, LLC20184—
+4K173722PATRIOT COLONIAL Spacer, SUSTAIN SpacerGlobus Medical, Inc.201894—
+4K173125T2 STRATOSPHERE™ Expandable Corpectomy SystemMedtronic Sofamor Danek201747—
+4K173115COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and…Globus Medical, Inc.201783—
+4K171689ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2017109—
+4K170157INDEPENDENCE® SpacersGlobus Medical, Inc.2017109—
+4K172199ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT…Medtronic Sofamor Danek20176—
+4K163422Shanghai Sanyou PEEK Cage SystemShanghai Sanyou Medical Co, Ltd.20173—
+4K171567IRIX-A Lumbar Integrated Fusion SystemX-Spine Systems, Inc.201701
+4K171075Calix-C Cervical Interbody SpacerX-Spine Systems, Inc.201715—
+4K171031CRESCENT™ Spinal SystemMedtronic Sofamor Danek2017144—
+4K163481HALF DOME Posterior Lumbar Interbody SystemAstura Medical201731—
+4K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+4K161223TransContinental® M Spacers and InterContinental® Plate-SpacersGlobus Medical, Inc.2016117—
+4K153123Genesys Spine Apache Interbody Fusion SystemGenesys Spine201612—
+4K160418PERIMETER Interbody Fusion DeviceMedtronic Sofamor Danek USA, Inc.20165—
+4K153589CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.201610—
+4K151481Sahara Stabilization SystemK2m, Inc.20155—
+4K151408LOSPA IS Spinal SystemCorentec Co., Ltd.20151—
+4K151056Aesculap T-Space PEEK and XP Spinal SystemAesculap Implant Systems, LLC20150—
+4K150847Foundation Interbody DevicesCorelink, LLC201529—
+4K151184InFill Interbody Fusion DevicesPinnacle Spine Group, LLC20153—
+4K142559ELEVATE Spinal SystemMedtronic Sofamor Danek USA, Inc.2015130—
+4K141665NuVasive CoRoent SystemNuvasive, Inc.2015588—
+4K143375CD HORIZON Spinal System, Medtronic Navigated Reusable InstrumentsMedtronic Sofamor Danek USA, Inc.2015207—
+4K143569CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.201515—
+4K142591CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.2014212—
+4K141604CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.201494—
+4K141443Infront Lumbar Interbody Fusion SystemInfront Medical, LLC20142—
+4K141494CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2014273—
+4K132907Plif Lite and Tlif LiteSintea Plustek20140—
+4K133893Sterispine LC CageSafe Orthopaedics20141—
+4K131292Deroyal Spine Spacer SystemDeroyal Industries, Inc.20140—
+4K123758Tasmin RSignus Medizintechnik GmbH20141—
+4K133645Perimeter C Spinal System, Capstone Spinal System, Capstone L Spinal System, Perimeter…Medtronic Sofamor Danek USA, Inc.20146—
+4K132897Clydesdale Spinal SystemMedtronic Sofamor Danek, Inc.2013279—
+4K132328CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013176—
+4K132639CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013243—
+4K133216Crescent Spinal SystemMedtronic Sofamor Danek, Inc.201392—
+4K132718Integrity Spine Core SystemIntegrity Spine20131—
+4K132014GSB Global Spinal Balance SystemNuvasive, Inc.201382—
+4K132471CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013132—
+4K132700Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek, Inc.2013170—
+4K131296Varilift-L Interbody Fusion DeviceWenzel Spine, Inc.20130—
+4K132111CD Horizon Spinal SystemMedtronic Sofamor Danek USA2013100—
+4K131671MectalifMedacta International201322—
+4K122037Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion System Peek Prevail…Medtronic Sofamor Danek, Inc.2013281—
+4K123809CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20136—
+4K123206Maxim Surgical X-Treme Interbody Fusion SystemMaxim Surgical2013454—
+4K120464Innesis Peek CageBk Meditech, Co., Ltd.20136—
+4K123388K7C SpacerK7, LLC20130—
+4K122862CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2012211—
+4K121760Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2012723—
+4K121982Sovereign Spinal SystemMedtronic Sofamor Danek2012155—
+4K121680CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2012357—
+4K120345Honour Spacer SystemNexxt Spine, LLC2012212—