510(k) Report

Devices descending from K010930

2,053 later devices reach Lift VB Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K071726ZUMASeaspine, Inc.200712—
+4K070173Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc.2007648—
+4K063491T2 Sceptor Spinal SystemMedtronic Sofamor Danek200753—
+4K063417Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek2007576—
+4K063083Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.20060—
+4K062133Modification to Verte-Stack Spinal SystemMedtronic Spinal and Biologics Div2006649—
+4K062427Verte-Stack Spinal SystemMedtronic Sofamor Danek2006151—
+4K062132Avs PL Peek Spacer SystemStryker Spine2006243—
+4K062073Verte-Stack Spinal SystemMedtronic Sofamor Danek2006844—
+4K060506Stryker Spine Vlift Vertebral Body Replacement SystemStryker Spine2006270—
+4K052670Staxx XD SystemSpine Wave, Inc.20068—
+4K053508Synfix-LRSynthes Spine Co.Lp2006391
+4K053292Davantis/Antelys Vertebral Body ReplacementsScient'X USA, Inc.20060—
+4K053474CD Horizon Spinal SystemMedtronic Sofamor Danek2006657—
+4K053101CD Horizon Spinal SystemMedtronic Sofamor Danek2006778—
+4K051781Graftcage TLXOsteotech, Inc.20050Class I
+4K051205Stryker Spine Avs Asl Peek SpacerStryker Spine2005829—
+4K051246Construx Mini Peek VBR SystemBlackstone Medical, Inc.2005834—
+4K051105Basis Vertebral Body SpacerMedtronic Sofamor Danek20050—
+5K261810Vertiwedge® Intraosseous SystemFoundation Surgical Group20260—
+5K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+5K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+5K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+5K260810Anteralign LS coverplateTyber Medical, LLC20260—
+5K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+5K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+5K242303MOD-COrthomod, LLC20260—
+5K254017SWINGO-3D Lumbar Cage SystemImplanet20260—
+5K254165Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20260—
+5K253941CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)Medtronic Sofamor Danek USA, Inc.20260—
+5K253577IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)Medicrea International S.A.S. (Medtronic)20250—
+5K252729Universal Spinal SystemDouble Medical Technology, Inc.20250—
+5K252351UniSpace® TPLIF CageCg Medtech Co., Ltd.20250—
+5K252742Navigated InstrumentsTyber Medical, LLC20251—
+5K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+5K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+5K251016MectaLIF 3D MetalMedacta International S.A.20250—
+5K250908Virata Spinal Fixation SystemSeaSpine Orthopedics Corporation202521
+5K250669Adaptix™ Interbody System with Titan nanoLOCK™ Surface TechnologyMedtronic Sofamor Danek USA, Inc.20250—
+5K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+5K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+5K242267Gemini Medical Cage SystemZheJiang Decans Medical Devices Co., Ltd.20241—
+5K241438Signus Tetris™ St; Signus Tetris™ R StSignus Medizintechnik GmbH20240—
+5K241605Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spinal System…Nanovis, LLC20240—
+5K241396uCerv Flux™-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA, Inc.20240—
+5K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG20240—
+5K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, 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—
+5K233191TotalTi ACDF by SAGICOSpinal Analytics & Geometrical Implant Co, LLC20230—
+5K232345ATEC Posterior Navigated Disc Prep InstrumentsAlphatec Spine, Inc.20232—
+5K230478Acro Composites Interbody SystemAcro Composites, LLC20230—
+5K232481RIGEL™ 3DR Anterior Cervical Corpectomy SystemMiRus, LLC20230—
+5K232141CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System…Medtronic Sofamor Danek USA, Inc.20231—
+5K221138Titus Titanium Cervical by SAGICOSagico VA USA, LLC20231—
+5K230369EUROPA™ Navigated InstrumentsMiRus, LLC20230—
+5K230329F3D Interbody SystemCorelink, LLC20230—
+5K230219Eminent Spine 3D Lumbar Interbody Fusion SystemsEminent Spine, LLC20234—
+5K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+5K223043The Integrity Spine Core SystemIntegrity Spine20230—
+5K223146EVOLUTION SPINE Interbody SystemEvolution Spine20239—
+5K212701Eminent Spine 3D Cervical Interbody Fusion SystemEminent Spine20235—
+5K223494CD Horizon Spinal SystemMedtronic202317—
+5K222554EL CAPITAN Anterior Lumbar Interbody FusionAstura Medical20235—
+5K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+5K223200Curiteva Navigation SystemCuriteva, Inc.20230—
+5K222516Mercury® II Spinal SystemSpinal Elements, Inc.20223—
+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—
+5K220486Kentrospine PSS Pedicle Screw SystemRivarp Medical Private Limited20220—
+5K220724CD Horizon™ Spinal System and PASS LP™ Spinal SystemMedicrea International20221—
+5K213750VyLink™ Spinal Screw SystemVy Spine, LLC20221—
+5K214011Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal…Medtronic Sofamor Danek USA, Inc.20221—
+5K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+5K212524Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.202155—
+5K212831MectaLIF ExtensionMedacta International S.A.20211—
+5K211689KEYSTONE PEEK Cage SystemShanghai Sanyou Medical Co, Ltd.20212—
+5K203607MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20210—
+5K212007VERTICALE Navigation InstrumentsSilony Medical GmbH20214—
+5K211958CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.202115—
+5K211441Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.20219—
+5K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemNu Vasive, Incorporated20213—
+5K210637CD Horizon™ Spinal SystemMedtronic202134—
+5K201457Auxein Brand Vertaux 5.5 mm Pedicle Screw SystemAuxein Medical Private Limited/7116420212—
+5K200551MectaLIF Transforaminal TiPEEKMedacta Inernational SA20214—
+5K203573RESPONSE Navigation InstrumentsOrthoPediatrics Corp.20210—
+5K203683CarboClear Lumbar Cage SystemCarbofix Orthpedics, Ltd.20211—
+5K202495SIRION Lateral Lumbar Interbody FusionAstura Medical, LLC20216—
+5K201287Impulse Interbody Fusion SystemDegen Medical20208—
+5K200549Lucero Medical Cervical Cage SystemLucero Medical, LLC20200—
+5K200719NuVasive Navigation.S InstrumentsNu Vasive, Incorporated20204—
+5K201193SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202018—
+5K202065DOLOMITE Anterior Cervical Stabilization SystemAstura Medical, LLC20203—
+5K202771CD Horizon Spinal SystemMedtronic202021—
+5K201407CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.202054—
+5K201585Monterey AL Interbody SystemStryker Corporation202044
+5K201926CarboClear® Pedicle Screw System, CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202010—
+5K201251CarboClear Navigated InstrumentsCarboFix Orthopedics, Ltd.20209—
+5K192492EL CAPITAN Anterior Lumber Interbody SystemAstura Medical, LLC202010—
+5K192006SIRION Lateral Lumbar Interbody SystemAstura Medical, LLC202014—