510(k) Report

Devices descending from K003155

2,091 later devices reach Vertebral Body Replacement through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K132907Plif Lite and Tlif LiteSintea Plustek20140—
+5K140162AP Expandable Xlif SystemNuvasive, Inc.2014236—
+5K133893Sterispine LC CageSafe Orthopaedics20141—
+5K131292Deroyal Spine Spacer SystemDeroyal Industries, Inc.20140—
+5K123758Tasmin RSignus Medizintechnik GmbH20141—
+5K133645Perimeter C Spinal System, Capstone Spinal System, Capstone L Spinal System, Perimeter…Medtronic Sofamor Danek USA, Inc.20146—
+5K132897Clydesdale Spinal SystemMedtronic Sofamor Danek, Inc.2013279—
+5K132328CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013176—
+5K132639CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013243—
+5K133216Crescent Spinal SystemMedtronic Sofamor Danek, Inc.201392—
+5K132718Integrity Spine Core SystemIntegrity Spine20131—
+5K132014GSB Global Spinal Balance SystemNuvasive, Inc.201382—
+5K132471CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013132—
+5K132700Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek, Inc.2013170—
+5K131296Varilift-L Interbody Fusion DeviceWenzel Spine, Inc.20130—
+5K132111CD Horizon Spinal SystemMedtronic Sofamor Danek USA2013100—
+5K131671MectalifMedacta International201322—
+5K122037Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion System Peek Prevail…Medtronic Sofamor Danek, Inc.2013281—
+5K123809CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20136—
+5K123206Maxim Surgical X-Treme Interbody Fusion SystemMaxim Surgical2013454—
+5K120464Innesis Peek CageBk Meditech, Co., Ltd.20136—
+5K123388K7C SpacerK7, LLC20130—
+5K122862CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2012211—
+5K121760Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2012723—
+5K121982Sovereign Spinal SystemMedtronic Sofamor Danek2012155—
+5K121680CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2012357—
+5K120345Honour Spacer SystemNexxt Spine, LLC2012212—
+5K120368Capstone Control Spinal SystemMedtronic Sofamor Danek USA, Inc.2012761—
+5K120024Mectalif TransforaminalMedacta International S.A.201223—
+5K113529CD Horizon Voyager Spinal SystemMedtronic Sofamor Danek2012316—
+5K113642Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek USA2012292—
+5K110896Reliance Spinal Screw SystemReliance Medical Systems, LLC20125—
+5K113528Clydesdale (R) Spinal SystemMedtronic Sofamor Danek USA, Inc.2011361—
+5K113174CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20115961
+5K112473CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2011597—
+5K112014Zyston Straight Spacer SystemBiomet Spine2011174—
+5K111264Cornerstone (R) PSR Cervical Fusion SystemMedtronic Sofamor Danek USA2011331—
+5K112555CD Horizon (R) Spinal SystemMedtronic Sofamor Danek USA, Inc.2011597—
+5K111510CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2011128—
+5K110659Medical Concepts Interbody Fusion SystemMedical Concepts, Inc.20111—
+5K111525Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek2011355—
+5K110543Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc.2011808—
+5K111571Viper SystemsJohnson & Johnson2011203—
+5K110927MectalifMedacta International2011301
+5K103034Genesys Spine Interbody Fusion SystemGenesys Spine20101371
+5K102807CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2010517—
+5K102555CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2010598—
+5K101112Reliance Spinal Screw SystemReliance Medical Systems20107—
+5K100042Difusion Technologies Xiphos Interbody Fusion SystemDifusion Technologies2010864—
+5K100214Cornerstone PSR Cervical Interbody Fusion DeviceMedtronic Sofamor Danek2010389—
+5K092540C-PS Peek Optima Cervical Interbody Spacer, L-PS Peek Optima Lumbar Interbody SpacerRsb Spine, LLC201045—
+5K092904Pathway Ivb/VBRCustom Spine, Inc.2009296—
+5K091442CD Horizon Spinal SystemMedtronic Sofamor Danek2009776—
+5K091088LDR Spine Cervical Interbody Fusion SystemLdr Spine USA2009901—
+5K090064Eminent Spine Interbody Fusion SystemEminent Spine20097011
+5K081978Reliance Spinal Screw SystemReliance Medical Systems, LLC20098—
+5K083825Eoi Spinal SystemExpanding Orthopedics, Inc.20090—
+5K083311Aesculap Cespace Peek Intervertebral Body Fusion SystemAesculap Implant Systems, Inc.2009554—
+5K083857LDR Spine Roi-C ImplantLdr Spine USA2009902—
+5K082353Mercury Spinal SystemSpinal Elements, Inc.200911—
+5K083230Mercury Spinal SystemSpinal Elements, Inc.200811—
+5K082342Modification to Capstone Spinal SystemMedtronic Sofamor Danek2008716—
+5K080971Spinesmith Cimplicity Spinal SystemSpine Smith Partners L.P.2008406—
+5K080728LDR Spine Roi-C ImplantLdr Spine USA2008903—
+5K071983Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace, Prospace, T-SpaceAesculap Implant Systems, Inc.20087881
+5K080572LDR Spine Roi-a ImplantLdr Spine USA2008113—
+5K073143Modified Vertiflex Spinal Screw SystemVertiflex, Inc.20080—
+5K071726ZUMASeaspine, Inc.200712—
+5K071033T2 XVBR Spinal SystemMedtronic Sofamor Danek200750—
+5K070173Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc.2007648—
+5K063491T2 Sceptor Spinal SystemMedtronic Sofamor Danek200753—
+5K063417Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek2007576—
+5K063083Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.20060—
+5K062133Modification to Verte-Stack Spinal SystemMedtronic Spinal and Biologics Div2006649—
+5K062427Verte-Stack Spinal SystemMedtronic Sofamor Danek2006151—
+5K062132Avs PL Peek Spacer SystemStryker Spine2006243—
+5K062073Verte-Stack Spinal SystemMedtronic Sofamor Danek2006844—
+5K060506Stryker Spine Vlift Vertebral Body Replacement SystemStryker Spine2006270—
+5K052670Staxx XD SystemSpine Wave, Inc.20068—
+5K053508Synfix-LRSynthes Spine Co.Lp2006391
+5K053292Davantis/Antelys Vertebral Body ReplacementsScient'X USA, Inc.20060—
+5K053474CD Horizon Spinal SystemMedtronic Sofamor Danek2006657—
+5K053101CD Horizon Spinal SystemMedtronic Sofamor Danek2006778—
+5K051781Graftcage TLXOsteotech, Inc.20050Class I
+5K051205Stryker Spine Avs Asl Peek SpacerStryker Spine2005829—
+5K051246Construx Mini Peek VBR SystemBlackstone Medical, Inc.2005834—
+5K051105Basis Vertebral Body SpacerMedtronic Sofamor Danek20050—
+5K043561Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2004999—
+6K261408SABER-XA SystemElevation Spine20260—
+6K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+6K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+6K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+6K260810Anteralign LS coverplateTyber Medical, LLC20260—
+6K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+6K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+6K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+6K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+6K242303MOD-COrthomod, LLC20260—
+6K254017SWINGO-3D Lumbar Cage SystemImplanet20260—
+6K254165Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20260—