510(k) Report

Devices descending from K021791

2,047 later devices reach Verte-Stack Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K132897Clydesdale Spinal SystemMedtronic Sofamor Danek, Inc.2013279—
+3K132328CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013176—
+3K132639CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013243—
+3K133216Crescent Spinal SystemMedtronic Sofamor Danek, Inc.201392—
+3K132718Integrity Spine Core SystemIntegrity Spine20131—
+3K132014GSB Global Spinal Balance SystemNuvasive, Inc.201382—
+3K132471CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013132—
+3K132700Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek, Inc.2013170—
+3K131296Varilift-L Interbody Fusion DeviceWenzel Spine, Inc.20130—
+3K132111CD Horizon Spinal SystemMedtronic Sofamor Danek USA2013100—
+3K131671MectalifMedacta International201322—
+3K122037Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion System Peek Prevail…Medtronic Sofamor Danek, Inc.2013281—
+3K123809CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20136—
+3K123206Maxim Surgical X-Treme Interbody Fusion SystemMaxim Surgical2013454—
+3K120464Innesis Peek CageBk Meditech, Co., Ltd.20136—
+3K123388K7C SpacerK7, LLC20130—
+3K122862CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2012211—
+3K121760Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2012723—
+3K121982Sovereign Spinal SystemMedtronic Sofamor Danek2012155—
+3K121680CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2012357—
+3K120345Honour Spacer SystemNexxt Spine, LLC2012212—
+3K120368Capstone Control Spinal SystemMedtronic Sofamor Danek USA, Inc.2012761—
+3K120024Mectalif TransforaminalMedacta International S.A.201223—
+3K113529CD Horizon Voyager Spinal SystemMedtronic Sofamor Danek2012316—
+3K113642Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek USA2012292—
+3K110896Reliance Spinal Screw SystemReliance Medical Systems, LLC20125—
+3K113528Clydesdale (R) Spinal SystemMedtronic Sofamor Danek USA, Inc.2011361—
+3K113174CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20115961
+3K112473CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2011597—
+3K112014Zyston Straight Spacer SystemBiomet Spine2011174—
+3K111264Cornerstone (R) PSR Cervical Fusion SystemMedtronic Sofamor Danek USA2011331—
+3K112555CD Horizon (R) Spinal SystemMedtronic Sofamor Danek USA, Inc.2011597—
+3K111510CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2011128—
+3K110659Medical Concepts Interbody Fusion SystemMedical Concepts, Inc.20111—
+3K111525Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek2011355—
+3K110543Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc.2011808—
+3K111571Viper SystemsJohnson & Johnson2011203—
+3K110927MectalifMedacta International2011301
+3K103034Genesys Spine Interbody Fusion SystemGenesys Spine20101371
+3K102807CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2010517—
+3K102555CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2010598—
+3K101112Reliance Spinal Screw SystemReliance Medical Systems20107—
+3K100042Difusion Technologies Xiphos Interbody Fusion SystemDifusion Technologies2010864—
+3K100214Cornerstone PSR Cervical Interbody Fusion DeviceMedtronic Sofamor Danek2010389—
+3K092540C-PS Peek Optima Cervical Interbody Spacer, L-PS Peek Optima Lumbar Interbody SpacerRsb Spine, LLC201045—
+3K092904Pathway Ivb/VBRCustom Spine, Inc.2009296—
+3K091442CD Horizon Spinal SystemMedtronic Sofamor Danek2009776—
+3K091088LDR Spine Cervical Interbody Fusion SystemLdr Spine USA2009901—
+3K090064Eminent Spine Interbody Fusion SystemEminent Spine20097011
+3K081978Reliance Spinal Screw SystemReliance Medical Systems, LLC20098—
+3K083825Eoi Spinal SystemExpanding Orthopedics, Inc.20090—
+3K083311Aesculap Cespace Peek Intervertebral Body Fusion SystemAesculap Implant Systems, Inc.2009554—
+3K083857LDR Spine Roi-C ImplantLdr Spine USA2009902—
+3K082353Mercury Spinal SystemSpinal Elements, Inc.200911—
+3K083230Mercury Spinal SystemSpinal Elements, Inc.200811—
+3K082342Modification to Capstone Spinal SystemMedtronic Sofamor Danek2008716—
+3K080971Spinesmith Cimplicity Spinal SystemSpine Smith Partners L.P.2008406—
+3K080728LDR Spine Roi-C ImplantLdr Spine USA2008903—
+3K071983Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace, Prospace, T-SpaceAesculap Implant Systems, Inc.20087881
+3K080572LDR Spine Roi-a ImplantLdr Spine USA2008113—
+3K073143Modified Vertiflex Spinal Screw SystemVertiflex, Inc.20080—
+3K071726ZUMASeaspine, Inc.200712—
+3K071033T2 XVBR Spinal SystemMedtronic Sofamor Danek200750—
+3K070173Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc.2007648—
+3K063491T2 Sceptor Spinal SystemMedtronic Sofamor Danek200753—
+3K063417Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek2007576—
+3K063083Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.20060—
+3K062133Modification to Verte-Stack Spinal SystemMedtronic Spinal and Biologics Div2006649—
+3K062427Verte-Stack Spinal SystemMedtronic Sofamor Danek2006151—
+3K062132Avs PL Peek Spacer SystemStryker Spine2006243—
+3K062073Verte-Stack Spinal SystemMedtronic Sofamor Danek2006844—
+3K060506Stryker Spine Vlift Vertebral Body Replacement SystemStryker Spine2006270—
+3K052670Staxx XD SystemSpine Wave, Inc.20068—
+3K053508Synfix-LRSynthes Spine Co.Lp2006391
+3K053292Davantis/Antelys Vertebral Body ReplacementsScient'X USA, Inc.20060—
+3K053474CD Horizon Spinal SystemMedtronic Sofamor Danek2006657—
+3K053101CD Horizon Spinal SystemMedtronic Sofamor Danek2006778—
+3K051781Graftcage TLXOsteotech, Inc.20050Class I
+3K051205Stryker Spine Avs Asl Peek SpacerStryker Spine2005829—
+3K051246Construx Mini Peek VBR SystemBlackstone Medical, Inc.2005834—
+3K051105Basis Vertebral Body SpacerMedtronic Sofamor Danek20050—
+3K043561Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2004999—
+4K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+4K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+4K260810Anteralign LS coverplateTyber Medical, LLC20260—
+4K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+4K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+4K242303MOD-COrthomod, LLC20260—
+4K254017SWINGO-3D Lumbar Cage SystemImplanet20260—
+4K254165Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20260—
+4K253941CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)Medtronic Sofamor Danek USA, Inc.20260—
+4K252729Universal Spinal SystemDouble Medical Technology, Inc.20250—
+4K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+4K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+4K251016MectaLIF 3D MetalMedacta International S.A.20250—
+4K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+4K250908Virata Spinal Fixation SystemSeaSpine Orthopedics Corporation202521
+4K250669Adaptix™ Interbody System with Titan nanoLOCK™ Surface TechnologyMedtronic Sofamor Danek USA, Inc.20250—
+4K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+4K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—