510(k) Report

Devices descending from K031655

1,220 later devices reach CD Horizon Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K241663Eminent Spine 3D Titanium Pedicle Screw SystemEminent Spine20250—
+1K143200MIS Z-Pedicle Screw SystemZ-Medical GmbH & Co. KG201514—
+1K142591CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.2014212—
+1K133402K2M Modular HooksK2m, Inc.20140—
+1K133690True Spinal Fussion SystemInnovative Surgical Designs20140—
+1K133103Aversion Pedicle Screw SystemK7, LLC20140—
+1K130958True Spinal Fixation SystemInnovative Surgical Designs20131—
+1K132471CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013132—
+1K120891Tangors Multifunctional Posterior SystemUlrich GmbH & Co. KG201218—
+1K120074Foundation Spinal SystemThe Skeletal Design Partnership, Ltd.20122—
+1K113173Nanovis Spinal SystemNanovis, LLC20122—
+1K111883Smartloc Spinal Fixation SystemA-Spine Asia, Co., Ltd.20112—
+1K111510CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2011128—
+1K102853Flamenco Spinal Fixation SystemUlrich GmbH & Co. KG2011221
+1K101278Inertia Pedicle Screw SystemNexxt Spine, LLC2010111—
+1K093833Kapss Spinal SystemRobert Reid, Inc.20100—
+1K100377Diamondback Spinal SystemEminent Spine201029—
+1K091974Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20096561
+1K052187Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005780—
+1K043488Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek20051,128—
+1K042790CD Horizon Spinal SystemMedtronic Sofamor Danek2004546—
+1K042167Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2004658—
+1K041777Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek20041,130—
+1K042025Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.20049874
+1K041030Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek2004790—
+2K252730Fule Spinal Fixation SystemBeijing Fule Science & Technology Development Co., Ltd.20250—
+2K242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemEminent Spine20240—
+2K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+2K223494CD Horizon Spinal SystemMedtronic202317—
+2K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+2K221244CD Horizon™ Spinal SystemMedtronic202220—
+2K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+2K211958CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.202115—
+2K210637CD Horizon™ Spinal SystemMedtronic202134—
+2K203452Nano FortiFix® SystemNanovis, LLC20200—
+2K202771CD Horizon Spinal SystemMedtronic202021—
+2K201362CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System, Kyphon™ HV-R™ Bone CementMedtronic202038—
+2K193211Nano FortiFix® SystemNanovis Spine, LLC20201—
+2K192680Percusys® Plus Pedicle Screw SystemJoimax GmbH20190—
+2K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+2K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+2K182928CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201953—
+2K182119CD HORIZON™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201858—
+2K180458FOCUS Pedicle Screw SystemNvision Biomedical Technologies, LLC20181—
+2K180301AXIS 5.5 Lumbar Pedicle Screw SystemAxis Orthopaedics20180—
+2K180324Patriot Spinal Fixation SystemValorus Spine20180—
+2K173249CD HORIZON™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20181—
+2K173126Arisstos™ Spinal SystemIngenium Spine20171—
+2K171582NEO Pedicle Screw System™Neo Medical SA20170—
+2K163301CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.20162—
+2K161363Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201675—
+2K153589CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.201610—
+2K152604KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw SetMedtronic Sofamor Danek USA, Incorporated2016159—
+2K152968Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201583—
+2K151770Libra Pedicle Screw SystemSpinal Balance, Inc.20151—
+2K152457CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.2015145—
+2K151727Everest Spinal SystemK2m, Inc.201511—
+2K142835Iliad Pedicle Screw System and Zenius Pedicle Screw SystemMedyssey USA, Inc.20155—
+2K143375CD HORIZON Spinal System, Medtronic Navigated Reusable InstrumentsMedtronic Sofamor Danek USA, Inc.2015207—
+2K143569CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.201515—
+2K150178CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.201525—
+2K142655CB PROT II Posterior Spinal SystemChin Bone Technique Corp20150—
+2K143141CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.201416—
+2K141604CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.201494—
+2K134011General Spinal SystemChangzhou Dean Medical Instrument Co, Ltd.20140—
+2K141494CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2014273—
+2K141376Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx, Struxxure Anterior…Nexxt Spine, LLC2014106—
+2K140010Fortress Pedicle Screw SystemSpineology, Inc.201411—
+2K140276CD Horizon Spinal SystemMedtronic Sofamor Danek201485—
+2K133564Modification to Nautilus Spinal SystemLife Spine, LLC201413—
+2K132328CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013176—
+2K132412Inertia Mis Pedicle Screw SystemNexxt Spine, LLC2013107—
+2K132111CD Horizon Spinal SystemMedtronic Sofamor Danek USA2013100—
+2K131321CD Horizon Spinal SystemMedtronic Sofamor Danek USA2013195—
+2K122877Range Spinal System, Small StatureK2m, Inc.201334—
+2K122994Intramedullary Nail SystemWeigao Orthopaedic Device Co., Ltd.20137—
+2K130646CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013244—
+2K123717UcentumUlrich GmbH & Co. KG2013171
+2K122433CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.201239—
+2K121630Range Spinal SystemK2m, Inc.2012127—
+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—
+2K112555CD Horizon (R) Spinal SystemMedtronic Sofamor Danek USA, Inc.2011597—
+2K111301Instinct Java SystemZimmer Spine201131
+2K102555CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2010598—
+2K102807CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2010517—
+2K093434Vertex Reconstruction System and Vertex Select Reconstruction SystemMedtronic Sofamor Danek20097—
+2K093058TSRH Spinal SystemMedtronic Sofamor Danek, Inc.2009478—
+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—
+2K072317Modification to:TSRH Spinal SystemMedtronic Sofamor Danek USA, Inc.20076254
+2K071033T2 XVBR Spinal SystemMedtronic Sofamor Danek200750—
+2K063670Modifications to CD Horizon Spinal SystemMedtronic Sofamor Danek2007821—
+2K063083Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.20060—
+2K060615CD Horizon Spinal SystemMedtronic Sofamor Danek200682234
+2K061591Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2006660—