510(k) Report

Devices descending from K981676

1,218 later devices reach CD Horizon Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K210716CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsCarboFix Orthopedics, Ltd.20218—
+1K203317CarboClear X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20209—
+1K201926CarboClear® Pedicle Screw System, CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202010—
+1K182377CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.201839—
+1K161231Facilis™ Spinal SystemBaui Biotech Co., Ltd.20172—
+1K132328CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013176—
+1K121764CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.201245—
+1K111510CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2011128—
+1K101074Modification to: CD Horizon (R) Spinal SystemMedtronic Sofamor Danek USA, Inc.2010225—
+1K090390CD Horizon Spinal SystemMedtronic Sofamor Danek2009663—
+1K063083Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.20060—
+1K050060Laguna Pedicle Screw SystemAllez Spine, LLC20052127
+1K050484Basis Spinal SystemMedtronic Sofamor Danek, Inc.20050—
+1K043488Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek20051,128—
+1K041862CD Horizon Spinal SystemMedtronic Sofamor Danek2004880—
+1K042025Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.20049874
+1K041030Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek2004790—
+1K013885Blackstone Spinal Fixation System Posterior HooksBlackstone Medical, Inc.2002300—
+2K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+2K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+2K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+2K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+2K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+2K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+2K223494CD Horizon Spinal SystemMedtronic202317—
+2K221244CD Horizon™ Spinal SystemMedtronic202220—
+2K211958CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.202115—
+2K210637CD Horizon™ Spinal SystemMedtronic202134—
+2K202505GetSet Surgical GoPLF! Posterior Lateral Fusion SystemGetset Surgical, SA20210—
+2K202771CD Horizon Spinal SystemMedtronic202021—
+2K200596G21 Cement, VADER® Pedicle SystemIcotec AG2020271
+2K201362CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System, Kyphon™ HV-R™ Bone CementMedtronic202038—
+2K190600ORION Spinal SystemOrion Biotech, Inc.20200—
+2K201251CarboClear Navigated InstrumentsCarboFix Orthopedics, Ltd.20209—
+2K193423VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG202061
+2K200519CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202011—
+2K190526High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics, Ltd.201928—
+2K191494Facilis™ Spinal SystemBaui Biotech Co., Ltd.20190—
+2K190545VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG2019291
+2K182119CD HORIZON™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201858—
+2K181139OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20188—
+2K173249CD HORIZON™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20181—
+2K173126Arisstos™ Spinal SystemIngenium Spine20171—
+2K152604KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw SetMedtronic Sofamor Danek USA, Incorporated2016159—
+2K142835Iliad Pedicle Screw System and Zenius Pedicle Screw SystemMedyssey USA, Inc.20155—
+2K143569CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.201515—
+2K150178CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.201525—
+2K142360Everest Spinal SystemK2m, Inc.201522—
+2K141253New Era Orthopaedics Polyscrew Pedicle Screw SystemNew Era Orthopaedics, LLC201511
+2K142591CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.2014212—
+2K143141CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.201416—
+2K141604CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.201494—
+2K141147Range Spinal SystemK2m, Inc.20141—
+2K140529Everest Spinal SystemK2m, LLC201431—
+2K140449CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.201459—
+2K140276CD Horizon Spinal SystemMedtronic Sofamor Danek201485—
+2K133904CD Horizon Spinal System Growth Rod SetMedtronic Sofamor Danek USA201443—
+2K132111CD Horizon Spinal SystemMedtronic Sofamor Danek USA2013100—
+2K131321CD Horizon Spinal SystemMedtronic Sofamor Danek USA2013195—
+2K122877Range Spinal System, Small StatureK2m, Inc.201334—
+2K123552Instinct Java SystemZimmer Spine201301
+2K130646CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013244—
+2K122433CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.201239—
+2K121630Range Spinal SystemK2m, Inc.2012127—
+2K121115M.U.S.T Pedicle Screw SystemMedacta International2012431
+2K121680CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2012357—
+2K113529CD Horizon Voyager Spinal SystemMedtronic Sofamor Danek2012316—
+2K113174CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20115961
+2K112473CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2011597—
+2K103748Laguna Pedicle Screw SystemPhygen, LLC201115—
+2K103102Leucadia Pedicle Screw SystemPhygen, LLC20111—
+2K102555CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2010598—
+2K093434Vertex Reconstruction System and Vertex Select Reconstruction SystemMedtronic Sofamor Danek20097—
+2K093058TSRH Spinal SystemMedtronic Sofamor Danek, Inc.2009478—
+2K091974Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20096561
+2K090230Expedium Spine SystemDepuy Spine, Inc.2009462—
+2K081080TSRH Spinal SystemMedtronic Sofamor Danek2008614—
+2K082942Modfication to: Expedium Spine SystemDepuy Spine, Inc.2008518—
+2K082236CD Horizon Spinal SystemMedtronic Sofamor Danek2008779—
+2K072678Laguna Size 8 Pedicle ScrewAllez Spine, LLC200816—
+2K080407Blackstone SFS Parallel Rod ConnectorsBlackstone Medical, Inc.20082961
+2K072317Modification to:TSRH Spinal SystemMedtronic Sofamor Danek USA, Inc.20076254
+2K071033T2 XVBR Spinal SystemMedtronic Sofamor Danek200750—
+2K063670Modifications to CD Horizon Spinal SystemMedtronic Sofamor Danek2007821—
+2K060615CD Horizon Spinal SystemMedtronic Sofamor Danek200682234
+2K061591Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2006660—
+2K061162Bar Pedicle Screw Spinal Fixation System, Model 2020Applied Spine Technologies, Inc.2006131—
+2K060979Xia Titanium and 4.5 Spinal SystemsStryker Spine2006710—
+2K060203Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek20060—
+2K053474CD Horizon Spinal SystemMedtronic Sofamor Danek2006657—
+2K053101CD Horizon Spinal SystemMedtronic Sofamor Danek2006778—
+2K051275Laguna Monoaxial Pedicle Screw SystemAllez Spine, LLC2005121
+2K052144TSRH Spinal SystemMedtronic Sofamor Danek20056651
+2K052187Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005780—
+2K052054TSRH Spinal SystemMedtronic Sofamor Danek2005786—
+2K050809CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2005870—
+2K050981CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2005786—
+2K050079CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2005787—
+2K043321Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek20050—
+2K043151Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005880—