510(k) Report

Devices descending from K043565

834 later devices reach Modification to Dynesys Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K071879Zimmer Dto ImplantZimmer Spine, Inc.200711
+1K060615CD Horizon Spinal SystemMedtronic Sofamor Danek200682234
+1K060638Dynesys Spinal System with HA Coated ScrewsZimmer Spine, Inc.2006131
+2K101790Quantum Spinal System, Quantum MisPioneer Surgical Technology201110—
+2K101704Zimmer Dto Pin Press InstrumentZimmer Spine, Inc.20100—
+2K073143Modified Vertiflex Spinal Screw SystemVertiflex, Inc.20080—
+2K063670Modifications to CD Horizon Spinal SystemMedtronic Sofamor Danek2007821—
+3K192800Streamline TL Spinal Fixation SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20203—
+3K133153Spinefrontier Pedfuse Pedicle Screw SystemSpinefrontier, Inc.20141—
+3K130286Streamline Mis Spinal Fixation SystemPioneer Surgical Technology, Inc.201371
+3K110896Reliance Spinal Screw SystemReliance Medical Systems, LLC20125—
+3K101112Reliance Spinal Screw SystemReliance Medical Systems20107—
+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—
+3K082236CD Horizon Spinal SystemMedtronic Sofamor Danek2008779—
+3K073562Modification to Viper Spine SystemDepuy Spine, Inc.2008213—
+4K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+4K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+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—
+4K222516Mercury® II Spinal SystemSpinal Elements, Inc.20223—
+4K213750VyLink™ Spinal Screw SystemVy Spine, LLC20221—
+4K192396Streamline MIS Spinal Fixation SystemPioneer Surgical Technology, Inc.20190—
+4K191576Mercury® Spinal System, Overwatch® Spinal SystemSpinal Elements, Inc.20195—
+4K172967Mercury® Spinal SystemSpinal Elements, Inc.20185—
+4K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+4K162066Reliance Spinal Screw SystemReliance Medical Systems, LLC20163—
+4K152131Reliance Spinal Screw SystemReliance Medical Systems, LLC20154—
+4K151215Mercury Spinal SystemSpinal Elements, Inc.20158—
+4K143377PedFuse Pedicle Screw SystemSpinefrontier, Inc.20150—
+4K141372Mercury Spinal SystemSpinal Elements, Inc.20149—
+4K132014GSB Global Spinal Balance SystemNuvasive, Inc.201382—
+4K131100Streamline TL Spinal SystemPioneer Surgical Technology, Inc.20136—
+4K123521Reliance Spinal Screw SystemReliance Medical Systems, LLC20135—
+4K111571Viper SystemsJohnson & Johnson2011203—
+4K091974Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20096561
+4K091442CD Horizon Spinal SystemMedtronic Sofamor Danek2009776—
+4K091587Mercury Spinal SystemSpinal Elements, Inc.200910—
+5K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+5K250908Virata Spinal Fixation SystemSeaSpine Orthopedics Corporation202521
+5K243916Primus Spinal Fixation SystemSpinal Elements, Inc.20252—
+5K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+5K231744VyLink™ Spinal Screw SystemVy Spine, LLC20230—
+5K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+5K220486Kentrospine PSS Pedicle Screw SystemRivarp Medical Private Limited20220—
+5K221244CD Horizon™ Spinal SystemMedtronic202220—
+5K203607MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20210—
+5K210874Reliance Spinal Screw SystemReliance Medical Systems, LLC20212—
+5K201457Auxein Brand Vertaux 5.5 mm Pedicle Screw SystemAuxein Medical Private Limited/7116420212—
+5K193472OrthoCircle Spine Pedicle Screw SystemOrthocircle Spine20200—
+5K190981NEX-D2 Posterior Fixation SystemNext Orthosurgical20200—
+5K190636NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201913—
+5K191212CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated…Medos International SARL20190—
+5K190360LineSider™ Spinal SystemIntegrity Implants, Inc.201913—
+5K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+5K182119CD HORIZON™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201858—
+5K160989NuVasive® Reline® SystemNu Vasive, Incorporated201667—
+5K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A.20162—
+5K153589CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.201610—
+5K152277PIVOX (tm) Oblique Lateral Spinal SystemMedtronic Sofamor Danek USA, Inc.2015190—
+5K143684NuVasive Reline SystemNu Vasive, Incorporated201577—
+5K143375CD HORIZON Spinal System, Medtronic Navigated Reusable InstrumentsMedtronic Sofamor Danek USA, Inc.2015207—
+5K143569CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.201515—
+5K142737MAS PLIF Fixation systemNu Vasive, Incorporated20141—
+5K142499Reline SystemNu Vasive, Incorporated201478—
+5K141604CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.201494—
+5K141494CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2014273—
+5K133575Spinevision Lumis Cannulated Pedicle Screw Fixation System, Spinevision U.L.I.S. Pedicle…Spinevision S.A.20143—
+5K140696Streamline TL Spinal Fixation SystemPioneer Surgical Technology, Inc.20145—
+5K132328CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013176—
+5K132471CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013132—
+5K131810Osseus Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLC201314—
+5K132111CD Horizon Spinal SystemMedtronic Sofamor Danek USA2013100—
+5K123623Illico Mis Posterior Fixation SystemAlphatec Spine, Inc.201321
+5K121728Tiger Spine SystemCorelink, LLC201250—
+5K121172Reform Pedicle Screw SystemSpinal USA201233—
+5K121680CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2012357—
+5K121016Range Spinal System (Mesa and Denali)K2m, Inc.201238—
+5K121020Viper SystemDepuy Spine, Inc.201294—
+5K120696Tiger Spine SystemCorelink, LLC201241—
+5K113529CD Horizon Voyager Spinal SystemMedtronic Sofamor Danek2012316—
+5K113174CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20115961
+5K112473CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2011597—
+5K112555CD Horizon (R) Spinal SystemMedtronic Sofamor Danek USA, Inc.2011597—
+5K111510CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2011128—
+5K101971Syntec OS Spinal Fixation SystemSyntec Scientific Corp.20110—
+5K102555CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2010598—
+5K102807CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2010517—
+5K092325Modification to:CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20093—
+6K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+6K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+6K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+6K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+6K253941CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)Medtronic Sofamor Danek USA, Inc.20260—
+6K252729Universal Spinal SystemDouble Medical Technology, Inc.20250—
+6K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—