510(k) Report

Devices descending from K012254

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K120368Capstone Control Spinal SystemMedtronic Sofamor Danek USA, Inc.2012761—
+4K120024Mectalif TransforaminalMedacta International S.A.201223—
+4K113529CD Horizon Voyager Spinal SystemMedtronic Sofamor Danek2012316—
+4K113642Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek USA2012292—
+4K110896Reliance Spinal Screw SystemReliance Medical Systems, LLC20125—
+4K113528Clydesdale (R) Spinal SystemMedtronic Sofamor Danek USA, Inc.2011361—
+4K113174CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20115961
+4K112473CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2011597—
+4K112014Zyston Straight Spacer SystemBiomet Spine2011174—
+4K111264Cornerstone (R) PSR Cervical Fusion SystemMedtronic Sofamor Danek USA2011331—
+4K112555CD Horizon (R) Spinal SystemMedtronic Sofamor Danek USA, Inc.2011597—
+4K111510CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2011128—
+4K110659Medical Concepts Interbody Fusion SystemMedical Concepts, Inc.20111—
+4K111525Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek2011355—
+4K110543Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc.2011808—
+4K111571Viper SystemsJohnson & Johnson2011203—
+4K110927MectalifMedacta International2011301
+4K103034Genesys Spine Interbody Fusion SystemGenesys Spine20101371
+4K102807CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2010517—
+4K102555CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2010598—
+4K101112Reliance Spinal Screw SystemReliance Medical Systems20107—
+4K100042Difusion Technologies Xiphos Interbody Fusion SystemDifusion Technologies2010864—
+4K100214Cornerstone PSR Cervical Interbody Fusion DeviceMedtronic Sofamor Danek2010389—
+4K092540C-PS Peek Optima Cervical Interbody Spacer, L-PS Peek Optima Lumbar Interbody SpacerRsb Spine, LLC201045—
+4K092904Pathway Ivb/VBRCustom Spine, Inc.2009296—
+4K091442CD Horizon Spinal SystemMedtronic Sofamor Danek2009776—
+4K091088LDR Spine Cervical Interbody Fusion SystemLdr Spine USA2009901—
+4K090064Eminent Spine Interbody Fusion SystemEminent Spine20097011
+4K081978Reliance Spinal Screw SystemReliance Medical Systems, LLC20098—
+4K083825Eoi Spinal SystemExpanding Orthopedics, Inc.20090—
+4K083311Aesculap Cespace Peek Intervertebral Body Fusion SystemAesculap Implant Systems, Inc.2009554—
+4K083857LDR Spine Roi-C ImplantLdr Spine USA2009902—
+4K082353Mercury Spinal SystemSpinal Elements, Inc.200911—
+4K083230Mercury Spinal SystemSpinal Elements, Inc.200811—
+4K082342Modification to Capstone Spinal SystemMedtronic Sofamor Danek2008716—
+4K080971Spinesmith Cimplicity Spinal SystemSpine Smith Partners L.P.2008406—
+4K080728LDR Spine Roi-C ImplantLdr Spine USA2008903—
+4K071983Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace, Prospace, T-SpaceAesculap Implant Systems, Inc.20087881
+4K080572LDR Spine Roi-a ImplantLdr Spine USA2008113—
+4K073143Modified Vertiflex Spinal Screw SystemVertiflex, Inc.20080—
+4K071726ZUMASeaspine, Inc.200712—
+4K071033T2 XVBR Spinal SystemMedtronic Sofamor Danek200750—
+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—
+4K043561Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2004999—
+5K261408SABER-XA SystemElevation 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—
+5K253401SCRIPT™ Implant SystemGlobus 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—
+5K252219Cervical Interbody and VBR Fusion SystemSync Surgical20260—
+5K253941CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)Medtronic Sofamor Danek USA, Inc.20260—
+5K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+5K250560BEE HANGMedical GmbH20250—
+5K252729Universal Spinal SystemDouble Medical Technology, Inc.20250—
+5K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+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—
+5K243461Calibrate Interbody SystemsAlphatec Spine, 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—
+5K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+5K241605Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spinal System…Nanovis, LLC20240—
+5K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+5K241396uCerv Flux™-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA, Inc.20240—
+5K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+5K233359DOMINION Expandable Corpectomy SystemAstura Medical20242—
+5K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+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—
+5K232141CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System…Medtronic Sofamor Danek USA, Inc.20231—