510(k) Report

Devices descending from K001340

2,423 later devices reach Stackable Cage System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K111469Staxxsd SystemSpine Wave, Inc.20110—
+4K111571Viper SystemsJohnson & Johnson2011203—
+4K110650Zyston Arc Interbody SpacerBiomet Spine (Aka Ebi, LLC)2011177—
+4K103743Concorde Curve SystemJohnson & Johnson20110—
+4K102547Coroent Interlock SystemNuvasive, Inc.2011131—
+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—
+4K101310VU Apod Intervertebral Body Fusion DeviceTheken Spine, LLC2010480—
+4K100544Impix Lumbar Interbody DeviceMedicrea Technologies201001
+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—
+4K090315Staxx XD SystemSpine Wave, Inc.20096—
+4K091442CD Horizon Spinal SystemMedtronic Sofamor Danek2009776—
+4K091088LDR Spine Cervical Interbody Fusion SystemLdr Spine USA2009901—
+4K083714Endoskeleton TT Interbody Fusion Device (Ibd)Titan Spine, LLC2009412—
+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—
+4K081880Atlas Spine SpacerAtlas Spine, Inc.20080—
+4K082342Modification to Capstone Spinal SystemMedtronic Sofamor Danek2008716—
+4K080971Spinesmith Cimplicity Spinal SystemSpine Smith Partners L.P.2008406—
+4K080728LDR Spine Roi-C ImplantLdr Spine USA2008903—
+4K080860Creaspine Supstance Small Vertebral Body Replacement SystemCreaspine20080—
+4K080569LDR Spine Roi-T ImplantLdr Spine USA20080—
+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—
+4K072537Creaspine Supstance Vertebral Body Replacement SystemCreaspine Sas20071—
+4K071726ZUMASeaspine, Inc.200712—
+4K072120Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc.20071,405—
+4K072132LDR Spine Roi-T SystemLdr Spine USA20071—
+4K071033T2 XVBR Spinal SystemMedtronic Sofamor Danek200750—
+4K071497Atlas Spine Vertebral Body ReplacementAtlas Spine, Inc.20070—
+4K070218Vertiflex Octane Peek Vertebral Body Replacement (Peek VBR)Vertiflex (Tm), Incorporated200760—
+4K070173Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc.2007648—
+4K063491T2 Sceptor Spinal SystemMedtronic Sofamor Danek200753—
+4K063417Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek2007576—
+4K061082Mobis Spinal ImplantSignus Medizintechnik GmbH20060—
+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—
+4K061151Pioneer Vertebral Spacer (Vertebral Spacer)Pioneer Surgical Technology2006801—
+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
+4K052210Nuvasive Coroent Extensure SystemNuvasive, Inc.2005263—
+4K051205Stryker Spine Avs Asl Peek SpacerStryker Spine2005829—
+4K051454Aleutian Spacer SystemK2m, LLC2005666—
+4K051659Semial Spinal ImplantSignus Medizintechnik GmbH2005790—
+4K051246Construx Mini Peek VBR SystemBlackstone Medical, Inc.2005834—
+4K051105Basis Vertebral Body SpacerMedtronic Sofamor Danek20050—
+4K043316Rabea Spinal ImplantSignus Medizintechnik GmbH20051,005—
+4K043561Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2004999—
+5K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+5K261049Scala® TLSpineart SA20260—
+5K261408SABER-XA SystemElevation Spine20260—
+5K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+5K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+5K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+5K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+5K260810Anteralign LS coverplateTyber Medical, LLC20260—
+5K253894BMD Titanium Spinal Fusion SystemGlobal Biomedica s.r.o.20260—
+5K260840BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20261—
+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—
+5K253260ORIO-3D Cage SystemSpineCraft20260—
+5K254017SWINGO-3D Lumbar Cage SystemImplanet20260—
+5K253583LUX Expandable Lumbar Interbody SystemXenix Medical20260—
+5K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+5K250773Luna® Ti Interbody Fusion SystemSpinal Elements, Inc.20260—
+5K253748Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer SystemLife Spine, Inc.20260—
+5K254165Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20260—
+5K253266Titanium Interbody SystemSpine Innovation, LLC20260—
+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—
+5K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+5K250764SpineLinc Anterior Cervical Implant SystemLincotek Medical20250—
+5K252610ZSFab Lumbar Interbody SystemZsfab, Inc.20251—
+5K250769Dakota LP SystemPrecision Spine, Inc.20250—
+5K250560BEE HANGMedical GmbH20250—
+5K252729Universal Spinal SystemDouble Medical Technology, Inc.20250—
+5K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+5K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+5K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+5K250076Endeavor™ Stand-Alone Cervical IBF SystemInnovasis20250—
+5K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—
+5K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—