510(k) Report

Devices descending from K031511

902 later devices reach Dynesys Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K073439Transition Stabilization SystemGlobus Medical, Inc.20092—
+1K073143Modified Vertiflex Spinal Screw SystemVertiflex, Inc.20080—
+1K071879Zimmer Dto ImplantZimmer Spine, Inc.200711
+1K061774Nfix II Pedicle Screw SystemN Spine, Inc.200627
+1K061162Bar Pedicle Screw Spinal Fixation System, Model 2020Applied Spine Technologies, Inc.2006131—
+1K060638Dynesys Spinal System with HA Coated ScrewsZimmer Spine, Inc.2006131
+1K050809CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2005870—
+1K043565Modification to Dynesys Spinal SystemZimmer Spine, Inc.20058341
+2K182928CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201953—
+2K133153Spinefrontier Pedfuse Pedicle Screw SystemSpinefrontier, Inc.20141—
+2K101790Quantum Spinal System, Quantum MisPioneer Surgical Technology201110—
+2K101704Zimmer Dto Pin Press InstrumentZimmer Spine, Inc.20100—
+2K092624Firebird Spinal Fixation SystemBlackstone Medical, Inc.20091301
+2K091974Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20096561
+2K082236CD Horizon Spinal SystemMedtronic Sofamor Danek2008779—
+2K073562Modification to Viper Spine SystemDepuy Spine, Inc.2008213—
+2K072685Ngarde SystemN Spine, Inc.200709
+2K063670Modifications to CD Horizon Spinal SystemMedtronic Sofamor Danek2007821—
+2K060615CD Horizon Spinal SystemMedtronic Sofamor Danek200682234
+2K061915CD Horizon Spinal SystemMedtronic Sofamor Danek200654—
+2K052747Modification to:CD Horizon Spinal SystemMedtronic Sofamor Danek2005528—
+2K052609Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek200554—
+2K052187Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005780—
+2K051674CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2005587—
+3K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+3K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+3K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+3K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+3K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+3K221244CD Horizon™ Spinal SystemMedtronic202220—
+3K203678CD HORIZON™ Spinal SystemMedtronic Sofamor Danek USA, Inc.202135—
+3K202328CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20200—
+3K200519CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202011—
+3K192800Streamline TL Spinal Fixation SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20203—
+3K191066CD Horizon™ Astute™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201921—
+3K182119CD HORIZON™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201858—
+3K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+3K153589CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.201610—
+3K143375CD HORIZON Spinal System, Medtronic Navigated Reusable InstrumentsMedtronic Sofamor Danek USA, Inc.2015207—
+3K143569CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.201515—
+3K143377PedFuse Pedicle Screw SystemSpinefrontier, Inc.20150—
+3K142591CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.2014212—
+3K141604CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.201494—
+3K141494CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2014273—
+3K132328CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013176—
+3K132639CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013243—
+3K132014GSB Global Spinal Balance SystemNuvasive, Inc.201382—
+3K132471CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013132—
+3K132644Lospa IS Pedicle Screw (Monoaxial & Polyaxial), Lospa IS Rod- Straight (Standard), Lospa…Corentec Co., Ltd.20130—
+3K132111CD Horizon Spinal SystemMedtronic Sofamor Danek USA2013100—
+3K130286Streamline Mis Spinal Fixation SystemPioneer Surgical Technology, Inc.201371
+3K123809CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20136—
+3K122901Firebird Spinal Fixation System, Phoenix Mis Spinal Fixation SystemOrthofix2012116—
+3K122862CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2012211—
+3K121680CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2012357—
+3K113529CD Horizon Voyager Spinal SystemMedtronic Sofamor Danek2012316—
+3K110896Reliance Spinal Screw SystemReliance Medical Systems, LLC20125—
+3K113174CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20115961
+3K112473CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2011597—
+3K112555CD Horizon (R) Spinal SystemMedtronic Sofamor Danek USA, Inc.2011597—
+3K111510CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2011128—
+3K111571Viper SystemsJohnson & Johnson2011203—
+3K111183Ascent Posterior Occipital Thoracic (Poct) System (Titanium & Cobalt Chrome Rods)Orthofix, Inc.201122—
+3K102807CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2010517—
+3K102555CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2010598—
+3K101112Reliance Spinal Screw SystemReliance Medical Systems20107—
+3K093926Firebird Spinal Fixation SystemBlackstone Medical, Inc.201088—
+3K100044Firebird Spinal Fixation System, Firebird Side-Loading BodyBlackstone2010117—
+3K091442CD Horizon Spinal SystemMedtronic Sofamor Danek2009776—
+3K081978Reliance Spinal Screw SystemReliance Medical Systems, LLC20098—
+3K083825Eoi Spinal SystemExpanding Orthopedics, Inc.20090—
+3K082353Mercury Spinal SystemSpinal Elements, Inc.200911—
+3K083230Mercury Spinal SystemSpinal Elements, Inc.200811—
+3K063417Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek2007576—
+3K063083Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.20060—
+3K053474CD Horizon Spinal SystemMedtronic Sofamor Danek2006657—
+3K053101CD Horizon Spinal SystemMedtronic Sofamor Danek2006778—
+4K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+4K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+4K254165Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20260—
+4K253941CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)Medtronic Sofamor Danek USA, Inc.20260—
+4K252729Universal Spinal SystemDouble Medical Technology, Inc.20250—
+4K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+4K250908Virata Spinal Fixation SystemSeaSpine Orthopedics Corporation202521
+4K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+4K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+4K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+4K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+4K232141CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System…Medtronic Sofamor Danek USA, Inc.20231—
+4K230369EUROPA™ Navigated InstrumentsMiRus, LLC20230—
+4K223494CD Horizon Spinal SystemMedtronic202317—
+4K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+4K223200Curiteva Navigation SystemCuriteva, Inc.20230—
+4K222516Mercury® II Spinal SystemSpinal Elements, Inc.20223—
+4K221646CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™…Medtronic Sofamor Danek USA, Inc.202220—
+4K220486Kentrospine PSS Pedicle Screw SystemRivarp Medical Private Limited20220—
+4K220724CD Horizon™ Spinal System and PASS LP™ Spinal SystemMedicrea International20221—
+4K213750VyLink™ Spinal Screw SystemVy Spine, LLC20221—
+4K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+4K203607MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20210—