510(k) Report

Devices descending from K011406

2,048 later devices reach Spinal Mesh System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K183197PYRAMESH™ Implant SystemMedtronic Sofamor Danek USA, Inc.20190—
+1K063491T2 Sceptor Spinal SystemMedtronic Sofamor Danek200753—
+1K021791Verte-Stack Spinal SystemMedtronic Sofamor Danek20022,047—
+2K091883T2 Spinal SystemMedtronic Sofamor Danek USA, Inc.200951—
+2K081383Reliance VBS SystemReliance Medical Systems, LLC20080—
+2K063637Reliance VBS SystemReliance Medical Systems, LLC20071—
+2K071033T2 XVBR Spinal SystemMedtronic Sofamor Danek200750—
+2K052261Modification to: Verte-Stack Spinal SystemMedtronic Sofamor Danek USA, Inc.2005839—
+2K050809CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2005870—
+2K042201Novel VBR Spinal SystemAlphatec/Nexmed2004796—
+2K041452Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2004815—
+2K033109Ellys and Aurys Vertebral Body ReplacementsScient'X20041,218—
+2K031780Verte-Stack Spinal SystemMedtronic Sofamor Danek20031,326—
+2K030735Modified Verte-Stack Spinal SystemMedtronic Sofamor Danek2003816—
+2K030736Verte-Stack Spinal System, Extra Small SizesMedtronic Sofamor Danek20031,101—
+2K030601Verte-Stack Spinal SystemMedtronic Sofamor Danek20031,151—
+2K023570Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek20021,383—
+3K183510T2 STRATOSPHERE Expandable Corpectomy SystemMedtronic Sofamor Danek USA, Inc.201927—
+3K182928CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201953—
+3K173125T2 STRATOSPHERE™ Expandable Corpectomy SystemMedtronic Sofamor Danek201747—
+3K131888T2 XVBR Spinal System, T2 Altitude Expandable Corpectomy DeviceMedtronic Sofamor Danek, Inc.20130—
+3K131082Interform Interbody Cage SystemNext Orthosurgical2013595—
+3K111294Santorini Spinal SystemK2m, Inc.201218—
+3K110562Telamon Peek Spinal SystemMedtronic Sofamor Danek USA2011306—
+3K100976T2 XVBR 1.5 Spinal SystemMedtronic Sofamor Danek USA, Inc.201049—
+3K094025Crescent Spinal SystemMedtronic Sofamor Danek2010838—
+3K090353Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek2009796—
+3K091974Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20096561
+3K082236CD Horizon Spinal SystemMedtronic Sofamor Danek2008779—
+3K073562Modification to Viper Spine SystemDepuy Spine, Inc.2008213—
+3K063670Modifications to CD Horizon Spinal SystemMedtronic Sofamor Danek2007821—
+3K060762Aesculap Peek Vertebral Body Replacement SystemAesculap, Inc.2006789—
+3K061752Spinal Usa VBR SystemSpinal USA20060—
+3K061938Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc.2006152—
+3K061915CD Horizon Spinal SystemMedtronic Sofamor Danek200654—
+3K060719Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2006992—
+3K052170Seaspine VBR SystemSeaspine, Inc.200513—
+3K052931Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2005993—
+3K052747Modification to:CD Horizon Spinal SystemMedtronic Sofamor Danek2005528—
+3K052609Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek200554—
+3K052187Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005780—
+3K051674CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2005587—
+3K043479MC+ Partial VBRLdr Spine USA20051,214—
+3K050348CO Vertebral Body ReplacementScient'X20052—
+3K050624Stryker Spine Avs PL Peek SpacerStryker Spine2005892—
+3K042571Stryker Spine Avs TL Peek SpacerStryker Spine2005894—
+3K043566Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2005726—
+3K042713Fidji-Vertebral Body Replacement Type 5Spine Next America Corporation20040—
+3K042714Fidji-Vertebral Body Replacement Type 1, 2, 3 and 4Spine Next America Corporation2004838—
+3K041197Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2004994—
+3K040731Stryker Spine Vertebral SpacerStryker Spine2004895—
+3K033926Hourglass Vertebral Body SpacerMedtronic Sofamor Danek2004763—
+3K041556Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek20041,002—
+3K040536Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek20041,150—
+3K040422Modification to Verte-StackMedtronic Sofamor Danek20041,002—
+4K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+4K241992Catalyft™ LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.20240—
+4K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+4K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+4K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+4K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+4K223153Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.20220—
+4K221244CD Horizon™ Spinal SystemMedtronic202220—
+4K214010Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA202249—
+4K210425Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.2021561
+4K203678CD HORIZON™ Spinal SystemMedtronic Sofamor Danek USA, Inc.202135—
+4K202328CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20200—
+4K201267Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek202079—
+4K200519CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202011—
+4K191788CAPSTONE Spinal System, CLYDESDALE PTC Spinal System, CRESCENT Spinal System, CRESCENT…Medtronic Sofamor Danek USA, Inc.20200—
+4K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+4K191066CD Horizon™ Astute™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201921—
+4K191537eCarbon IBDsBack 2 Basics Direct, LLC20193—
+4K191039Navigated T2 STRATOSPHERE Inserters and Navigated TemplatesMedtronic Sofamor Danek USA, Inc.201918—
+4K190165Capstone Control™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20196—
+4K181591Fixated Asfora BULLET CAGE® (FABC)Medical Designs, LLC20180—
+4K181328T2 STRATOSPHERE™ Expandable Corpectomy SystemMedtronic Sofamor Danek USA, Inc.201828—
+4K182119CD HORIZON™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201858—
+4K171689ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2017109—
+4K172199ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT…Medtronic Sofamor Danek20176—
+4K163422Shanghai Sanyou PEEK Cage SystemShanghai Sanyou Medical Co, Ltd.20173—
+4K171704CAPRI Corpectomy Cage SystemK2m201710—
+4K171031CRESCENT™ Spinal SystemMedtronic Sofamor Danek2017144—
+4K162133VerteFIT Corpectomy Cage SystemLdr Spine USA, Inc.20170—
+4K163481HALF DOME Posterior Lumbar Interbody SystemAstura Medical201731—
+4K170055CAPRI Corpectomy Cage SystemK2m201711—
+4K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+4K153123Genesys Spine Apache Interbody Fusion SystemGenesys Spine201612—
+4K160418PERIMETER Interbody Fusion DeviceMedtronic Sofamor Danek USA, Inc.20165—
+4K153589CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.201610—
+4K151481Sahara Stabilization SystemK2m, Inc.20155—
+4K151408LOSPA IS Spinal SystemCorentec Co., Ltd.20151—
+4K151056Aesculap T-Space PEEK and XP Spinal SystemAesculap Implant Systems, LLC20150—
+4K150847Foundation Interbody DevicesCorelink, LLC201529—
+4K151184InFill Interbody Fusion DevicesPinnacle Spine Group, LLC20153—
+4K142559ELEVATE Spinal SystemMedtronic Sofamor Danek USA, Inc.2015130—
+4K141665NuVasive CoRoent SystemNuvasive, Inc.2015588—
+4K143375CD HORIZON Spinal System, Medtronic Navigated Reusable InstrumentsMedtronic Sofamor Danek USA, Inc.2015207—
+4K143569CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.201515—
+4K142591CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.2014212—