510(k) Report

Devices descending from K062807

676 later devices reach TSRH Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K171369M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20178—
+5K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+5K161498Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20161—
+5K161149PASS OCT Spinal SystemMedicrea International SA20160—
+5K160756PASS OCT Spinal SystemMedicrea International SA20160—
+5K153169PASS OCT Patient Specific RodsMedicrea International20164—
+5K152211PCT SystemCentinel Spine, Inc.20150—
+5K151974Polaris Spinal SystemBiomet Spine201516—
+5K150896Vitality Spinal Fixation SystemZimmer Spine, Inc.2015193
+5K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+5K151196Nautilus Spinal SystemLife Spine, Inc.201512—
+5K150229SOLSTICE OCT SystemLife Spine, Inc.20150—
+5K143377PedFuse Pedicle Screw SystemSpinefrontier, Inc.20150—
+5K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+5K140123Polaris Spinal System -Translation ScrewEbi, LLC2014221
+5K133743Baxano Surgical Mis Spinal SystemBaxano Surgical, Inc.20140—
+5K132504Tiger Occipital-Cervical-Thoracic Spinal Fixation SystemCorelink, LLC20132—
+5K132760Nautilus Spinal SystemLife Spine, Inc.201314—
+5K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)201370—
+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
+6K254260The VEGA Cervical Screw SystemGS Medical Co., Ltd.20260—
+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—
+6K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+6K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+6K230325GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal SystemGreens Surgicals Pvt., Ltd.20240—
+6K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+6K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+6K223494CD Horizon Spinal SystemMedtronic202317—
+6K221244CD Horizon™ Spinal SystemMedtronic202220—
+6K220570M.U.S.T. MINI Posterior Cervical Screws System ExtensionMedacta International S.A.20220—
+6K220724CD Horizon™ Spinal System and PASS LP™ Spinal SystemMedicrea International20221—
+6K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+6K210637CD Horizon™ Spinal SystemMedtronic202134—
+6K210275Polaris Spinal SystemZimmer Biomet Spine, Inc.20210—
+6K202771CD Horizon Spinal SystemMedtronic202021—
+6K201407CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.202054—
+6K202328CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20200—
+6K200303Reform Pedicle Screw SystemPrecision Spine202010—
+6K200863Tiger® Occipital-Cervical-Thoracic Spinal Fixation SystemCorelink, LLC20200—
+6K200070ARx Spinal SystemLife Spine, Inc.20209—
+6K200130M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20206—
+6K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+6K192396Streamline MIS Spinal Fixation SystemPioneer Surgical Technology, Inc.20190—
+6K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+6K191575ARx Spinal SystemLife Spine, Inc.201910—
+6K191185Solanas® Posterior OCT Fixation SystemAlphatec Spine20194—
+6K183430Modular Spinal Fixation SystemLife Spine, Inc.20192—
+6K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+6K183080Mega Plus Spine SystemBk Meditech, Co., Ltd.20182—
+6K182119CD HORIZON™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201858—
+6K180433Ennovate®Aesculap Implant Systems, LLC201811
+6K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179—
+6K172139Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20170—
+6K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.20170—
+6K171907Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc.2017162
+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—
+6K150856Reform Pedicle Screw SystemPrecision Spine, Inc.201526—
+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—
+6K141804Polaris Spinal System - HA CoatedBiomet Spine, LLC201421—
+6K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+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—
+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—
+7K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+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—
+7K253545Vulcan Spinal SystemK2m, Inc.20260—
+7K252087Navigation Module of the Cortium® SystemUlrich Medical USA, Inc.20260—
+7K252962DYNAMIS™ Navigation SystemPromethean Restorative, LLC20260—
+7K253941CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)Medtronic Sofamor Danek USA, Inc.20260—
+7K250520OsteoCentric Navigated Instruments SystemOsteocentric Technologies, Inc.20250—
+7K252322SIros-X SystemGenesys Spine20250—