510(k) Report

Devices descending from K050809

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K182928CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201953—
+1K091974Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20096561
+1K082236CD Horizon Spinal SystemMedtronic Sofamor Danek2008779—
+1K073562Modification to Viper Spine SystemDepuy Spine, Inc.2008213—
+1K063670Modifications to CD Horizon Spinal SystemMedtronic Sofamor Danek2007821—
+1K061915CD Horizon Spinal SystemMedtronic Sofamor Danek200654—
+1K052747Modification to:CD Horizon Spinal SystemMedtronic Sofamor Danek2005528—
+1K052609Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek200554—
+1K052187Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005780—
+1K051674CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2005587—
+2K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+2K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+2K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+2K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+2K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+2K221244CD Horizon™ Spinal SystemMedtronic202220—
+2K203678CD HORIZON™ Spinal SystemMedtronic Sofamor Danek USA, Inc.202135—
+2K202328CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20200—
+2K200519CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202011—
+2K191066CD Horizon™ Astute™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201921—
+2K182119CD HORIZON™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201858—
+2K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+2K153589CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.201610—
+2K143375CD HORIZON Spinal System, Medtronic Navigated Reusable InstrumentsMedtronic Sofamor Danek USA, Inc.2015207—
+2K143569CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.201515—
+2K142591CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.2014212—
+2K141604CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.201494—
+2K141494CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2014273—
+2K132328CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013176—
+2K132639CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013243—
+2K132014GSB Global Spinal Balance SystemNuvasive, Inc.201382—
+2K132471CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013132—
+2K132111CD Horizon Spinal SystemMedtronic Sofamor Danek USA2013100—
+2K123809CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20136—
+2K122862CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2012211—
+2K121680CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2012357—
+2K113529CD Horizon Voyager Spinal SystemMedtronic Sofamor Danek2012316—
+2K110896Reliance Spinal Screw SystemReliance Medical Systems, LLC20125—
+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—
+2K111510CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2011128—
+2K111571Viper SystemsJohnson & Johnson2011203—
+2K102807CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2010517—
+2K102555CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2010598—
+2K101112Reliance Spinal Screw SystemReliance Medical Systems20107—
+2K091442CD Horizon Spinal SystemMedtronic Sofamor Danek2009776—
+2K081978Reliance Spinal Screw SystemReliance Medical Systems, LLC20098—
+2K083825Eoi Spinal SystemExpanding Orthopedics, Inc.20090—
+2K082353Mercury Spinal SystemSpinal Elements, Inc.200911—
+2K083230Mercury Spinal SystemSpinal Elements, Inc.200811—
+2K073143Modified Vertiflex Spinal Screw SystemVertiflex, Inc.20080—
+2K063417Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek2007576—
+2K063083Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.20060—
+2K053474CD Horizon Spinal SystemMedtronic Sofamor Danek2006657—
+2K053101CD Horizon Spinal SystemMedtronic Sofamor Danek2006778—
+3K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+3K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+3K254165Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20260—
+3K253941CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)Medtronic Sofamor Danek USA, Inc.20260—
+3K252729Universal Spinal SystemDouble Medical Technology, Inc.20250—
+3K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+3K250908Virata Spinal Fixation SystemSeaSpine Orthopedics Corporation202521
+3K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+3K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+3K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+3K232141CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System…Medtronic Sofamor Danek USA, Inc.20231—
+3K230369EUROPA™ Navigated InstrumentsMiRus, LLC20230—
+3K223494CD Horizon Spinal SystemMedtronic202317—
+3K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+3K223200Curiteva Navigation SystemCuriteva, Inc.20230—
+3K222516Mercury® II Spinal SystemSpinal Elements, Inc.20223—
+3K221646CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™…Medtronic Sofamor Danek USA, Inc.202220—
+3K220486Kentrospine PSS Pedicle Screw SystemRivarp Medical Private Limited20220—
+3K220724CD Horizon™ Spinal System and PASS LP™ Spinal SystemMedicrea International20221—
+3K213750VyLink™ Spinal Screw SystemVy Spine, LLC20221—
+3K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+3K203607MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20210—
+3K212007VERTICALE Navigation InstrumentsSilony Medical GmbH20214—
+3K211958CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.202115—
+3K210637CD Horizon™ Spinal SystemMedtronic202134—
+3K201457Auxein Brand Vertaux 5.5 mm Pedicle Screw SystemAuxein Medical Private Limited/7116420212—
+3K203573RESPONSE Navigation InstrumentsOrthoPediatrics Corp.20210—
+3K202771CD Horizon Spinal SystemMedtronic202021—
+3K201407CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.202054—
+3K201926CarboClear® Pedicle Screw System, CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202010—
+3K201251CarboClear Navigated InstrumentsCarboFix Orthopedics, Ltd.20209—
+3K193100RESPONSE™ Spine System, RESPONSE™ 4.5/5.0 Spine System, RESPONSE™ 5.5/6.0 Spine SystemOrthoPediatrics Corp.20204—
+3K193011CD Horizon™ Fenestrated Screw SetMedtronic Sofamor Danek USA, Inc.202041—
+3K190881Spinal Elements Navigated InstrumentsSpinal Elements, Inc.20194—
+3K190636NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201913—
+3K191212CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated…Medos International SARL20190—
+3K191576Mercury® Spinal System, Overwatch® Spinal SystemSpinal Elements, Inc.20195—
+3K190360LineSider™ Spinal SystemIntegrity Implants, Inc.201913—
+3K183630SPINEART Navigation Instrument SystemSpineart SA20196—
+3K183381Navigation Enabled InstrumentsStryker20191—
+3K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+3K182982BridalVeil Navigated InstrumentsAstura Medical20190—
+3K172166OLYMPIC Navigated InstrumentsAstura Medical20185—
+3K172967Mercury® Spinal SystemSpinal Elements, Inc.20185—