510(k) Report

Devices descending from K041282

633 later devices reach Modification to TSRH Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K072429Modification to TSRH Spinal SystemMedtronic Sofamor Danek200710—
+1K072317Modification to:TSRH Spinal SystemMedtronic Sofamor Danek USA, Inc.20076254
+2K110896Reliance Spinal Screw SystemReliance Medical Systems, LLC20125—
+2K101112Reliance Spinal Screw SystemReliance Medical Systems20107—
+2K092676TSRH Spinal SystemMedtronic Sofamor Danek, Inc.20090—
+2K090740Modification to: TSRH Spinal SystemMedtronic Sofamor Danek20091—
+2K081978Reliance Spinal Screw SystemReliance Medical Systems, LLC20098—
+2K081080TSRH Spinal SystemMedtronic Sofamor Danek2008614—
+2K073430Valeo Pedicle Screw Spinal SystemAmedica Corp.200824—
+3K213750VyLink™ Spinal Screw SystemVy Spine, LLC20221—
+3K162066Reliance Spinal Screw SystemReliance Medical Systems, LLC20163—
+3K162160Preference Elite Pedicle Screw SystemAmedica Corporation20161—
+3K151704Diplomat® Spinal SystemSignus Medizintechnik GmbH20164—
+3K152131Reliance Spinal Screw SystemReliance Medical Systems, LLC20154—
+3K143230Palladian Lumbar Pedicle Screw SystemNeurostructures, Inc.20150—
+3K141282PGS 5.5 MM Cannulated Pedicle ScrewPinnacle Spine Group20141—
+3K133287Presson Spinal Fixation SystemNexus Spine, LLC20141—
+3K123521Reliance Spinal Screw SystemReliance Medical Systems, LLC20135—
+3K091797TSRH Spinal SystemMedtronic Sofamor Danek2010606—
+3K080767Conquest Spinal SystemLife Spine200821—
+4K243281LOCK-IN Spinal Fixation SystemLock-In USA Corp20240—
+4K231744VyLink™ Spinal Screw SystemVy Spine, LLC20230—
+4K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+4K212185Golden Isles Pedicle Screw SystemIntelivation, LLC20210—
+4K210874Reliance Spinal Screw SystemReliance Medical Systems, LLC20212—
+4K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+4K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+4K160820PressON Pro Spinal Fixation SystemNexus Spine, LLC20160—
+4K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.201513—
+4K133153Spinefrontier Pedfuse Pedicle Screw SystemSpinefrontier, Inc.20141—
+4K123373Nautilus Spinal SystemLife Spine201317—
+4K111953Nautilus Spinal SystemLife Spine20123—
+4K112555CD Horizon (R) Spinal SystemMedtronic Sofamor Danek USA, Inc.2011597—
+4K101790Quantum Spinal System, Quantum MisPioneer Surgical Technology201110—
+4K090320Conquest Spinal SystemLife Spine20092—
+5K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+5K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+5K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+5K220025ARx® Spinal SystemLife Spine, Inc.20220—
+5K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+5K210549ARx Spinal SystemLife Spine, Inc.20211—
+5K192800Streamline TL Spinal Fixation SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20203—
+5K151196Nautilus Spinal SystemLife Spine, Inc.201512—
+5K143377PedFuse Pedicle Screw SystemSpinefrontier, Inc.20150—
+5K133743Baxano Surgical Mis Spinal SystemBaxano Surgical, Inc.20140—
+5K132760Nautilus Spinal SystemLife Spine, Inc.201314—
+5K122877Range Spinal System, Small StatureK2m, Inc.201334—
+5K130286Streamline Mis Spinal Fixation SystemPioneer Surgical Technology, Inc.201371
+5K113174CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20115961
+6K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+6K252729Universal Spinal SystemDouble Medical Technology, Inc.20250—
+6K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+6K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+6K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+6K223494CD Horizon Spinal SystemMedtronic202317—
+6K221244CD Horizon™ Spinal SystemMedtronic202220—
+6K220724CD Horizon™ Spinal System and PASS LP™ Spinal SystemMedicrea International20221—
+6K210637CD Horizon™ Spinal SystemMedtronic202134—
+6K202771CD Horizon Spinal SystemMedtronic202021—
+6K201407CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.202054—
+6K202328CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20200—
+6K200070ARx Spinal SystemLife Spine, Inc.20209—
+6K192396Streamline MIS Spinal Fixation SystemPioneer Surgical Technology, Inc.20190—
+6K191575ARx Spinal SystemLife Spine, Inc.201910—
+6K183430Modular Spinal Fixation SystemLife Spine, Inc.20192—
+6K182119CD HORIZON™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201858—
+6K170679CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC®…Medtronic Sofamor Danek201786—
+6K170347CD HORIZON™ Fenestrated Screw SetMedtronic Sofamor Danek USA201791—
+6K162379CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.201645—
+6K153442CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with…Medtronic Sofamor Danek USA, Inc.201684—
+6K152604KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw SetMedtronic Sofamor Danek USA, Incorporated2016159—
+6K152248CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.20150—
+6K152457CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.2015145—
+6K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+6K143569CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.201515—
+6K142847CD HORIZON Spinal SystemMedtronic Sofamor Danck USA, Inc.2014286—
+6K141604CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.201494—
+6K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+6K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014671
+6K133564Modification to Nautilus Spinal SystemLife Spine, LLC201413—
+6K132328CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013176—
+6K132639CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013243—
+6K132471CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013132—
+6K131100Streamline TL Spinal SystemPioneer Surgical Technology, Inc.20136—
+6K131321CD Horizon Spinal SystemMedtronic Sofamor Danek USA2013195—
+6K130646CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013244—
+6K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC)2013752
+6K122592Instinct Java SystemZimmer Spine201301
+6K122862CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2012211—
+6K122433CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.201239—
+6K121630Range Spinal SystemK2m, Inc.2012127—
+6K121115M.U.S.T Pedicle Screw SystemMedacta International2012431
+6K120564Calypso SystemHogan Lovells US LLP201216—
+6K121680CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2012357—
+7K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+7K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+7K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+7K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+7K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+7K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—