510(k) Report

Devices descending from K072317

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K090740Modification to: TSRH Spinal SystemMedtronic Sofamor Danek20091—
+1K081080TSRH Spinal SystemMedtronic Sofamor Danek2008614—
+1K073430Valeo Pedicle Screw Spinal SystemAmedica Corp.200824—
+2K162160Preference Elite Pedicle Screw SystemAmedica Corporation20161—
+2K151704Diplomat® Spinal SystemSignus Medizintechnik GmbH20164—
+2K143230Palladian Lumbar Pedicle Screw SystemNeurostructures, Inc.20150—
+2K141282PGS 5.5 MM Cannulated Pedicle ScrewPinnacle Spine Group20141—
+2K133287Presson Spinal Fixation SystemNexus Spine, LLC20141—
+2K091797TSRH Spinal SystemMedtronic Sofamor Danek2010606—
+2K092676TSRH Spinal SystemMedtronic Sofamor Danek, Inc.20090—
+2K080767Conquest Spinal SystemLife Spine200821—
+3K243281LOCK-IN Spinal Fixation SystemLock-In USA Corp20240—
+3K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+3K212185Golden Isles Pedicle Screw SystemIntelivation, LLC20210—
+3K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+3K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+3K160820PressON Pro Spinal Fixation SystemNexus Spine, LLC20160—
+3K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.201513—
+3K133153Spinefrontier Pedfuse Pedicle Screw SystemSpinefrontier, Inc.20141—
+3K123373Nautilus Spinal SystemLife Spine201317—
+3K111953Nautilus Spinal SystemLife Spine20123—
+3K112555CD Horizon (R) Spinal SystemMedtronic Sofamor Danek USA, Inc.2011597—
+3K101790Quantum Spinal System, Quantum MisPioneer Surgical Technology201110—
+3K090320Conquest Spinal SystemLife Spine20092—
+4K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+4K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+4K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+4K220025ARx® Spinal SystemLife Spine, Inc.20220—
+4K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+4K210549ARx Spinal SystemLife Spine, Inc.20211—
+4K192800Streamline TL Spinal Fixation SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20203—
+4K151196Nautilus Spinal SystemLife Spine, Inc.201512—
+4K143377PedFuse Pedicle Screw SystemSpinefrontier, Inc.20150—
+4K133743Baxano Surgical Mis Spinal SystemBaxano Surgical, Inc.20140—
+4K132760Nautilus Spinal SystemLife Spine, Inc.201314—
+4K122877Range Spinal System, Small StatureK2m, Inc.201334—
+4K130286Streamline Mis Spinal Fixation SystemPioneer Surgical Technology, Inc.201371
+4K113174CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20115961
+5K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+5K252729Universal Spinal SystemDouble Medical Technology, Inc.20250—
+5K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+5K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+5K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+5K223494CD Horizon Spinal SystemMedtronic202317—
+5K221244CD Horizon™ Spinal SystemMedtronic202220—
+5K220724CD Horizon™ Spinal System and PASS LP™ Spinal SystemMedicrea International20221—
+5K210637CD Horizon™ Spinal SystemMedtronic202134—
+5K202771CD Horizon Spinal SystemMedtronic202021—
+5K201407CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.202054—
+5K202328CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20200—
+5K200070ARx Spinal SystemLife Spine, Inc.20209—
+5K192396Streamline MIS Spinal Fixation SystemPioneer Surgical Technology, Inc.20190—
+5K191575ARx Spinal SystemLife Spine, Inc.201910—
+5K183430Modular Spinal Fixation SystemLife Spine, Inc.20192—
+5K182119CD HORIZON™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201858—
+5K170679CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC®…Medtronic Sofamor Danek201786—
+5K170347CD HORIZON™ Fenestrated Screw SetMedtronic Sofamor Danek USA201791—
+5K162379CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.201645—
+5K153442CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with…Medtronic Sofamor Danek USA, Inc.201684—
+5K152604KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw SetMedtronic Sofamor Danek USA, Incorporated2016159—
+5K152248CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.20150—
+5K152457CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.2015145—
+5K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+5K143569CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.201515—
+5K142847CD HORIZON Spinal SystemMedtronic Sofamor Danck USA, Inc.2014286—
+5K141604CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.201494—
+5K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+5K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014671
+5K133564Modification to Nautilus Spinal SystemLife Spine, LLC201413—
+5K132328CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013176—
+5K132639CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013243—
+5K132471CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013132—
+5K131100Streamline TL Spinal SystemPioneer Surgical Technology, Inc.20136—
+5K131321CD Horizon Spinal SystemMedtronic Sofamor Danek USA2013195—
+5K130646CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013244—
+5K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC)2013752
+5K122592Instinct Java SystemZimmer Spine201301
+5K122862CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2012211—
+5K122433CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.201239—
+5K121630Range Spinal SystemK2m, Inc.2012127—
+5K121115M.U.S.T Pedicle Screw SystemMedacta International2012431
+5K120564Calypso SystemHogan Lovells US LLP201216—
+5K121680CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2012357—
+6K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+6K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+6K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+6K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+6K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+6K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+6K252087Navigation Module of the Cortium® SystemUlrich Medical USA, Inc.20260—
+6K254165Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20260—
+6K252962DYNAMIS™ Navigation SystemPromethean Restorative, LLC20260—
+6K253941CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)Medtronic Sofamor Danek USA, Inc.20260—
+6K250520OsteoCentric Navigated Instruments SystemOsteocentric Technologies, Inc.20250—
+6K252322SIros-X SystemGenesys Spine20250—
+6K253331PressON Spinal Fixation SystemNexus Spine20250—
+6K243419Altus Spine Navigation SystemAltus Partners, LLC20250—
+6K250182Innovasis Navigation InstrumentsInnovasis, Inc.202521
+6K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+6K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—