510(k) Report

Devices descending from K982990

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K110676TSRH Spinal SystemMedtronic Sofamor Danek201136—
+1K093058TSRH Spinal SystemMedtronic Sofamor Danek, Inc.2009478—
+1K072317Modification to:TSRH Spinal SystemMedtronic Sofamor Danek USA, Inc.20076254
+1K030087Spinal Concepts, Inc. Bacfix TI Spinal SystemSpinal Concepts, Inc.20030—
+1K020356Alpha Mirage Top Tightening Spinal SystemAlphatec Mfg., Inc.20021—
+1K013447Isobar Spinal SystemScien'Tx USA, Inc.200238—
+1K013440Isobar Spinal SystemScien'Tx USA, Inc.200184—
+1K992738Isobar Spinal SystemEncore Orthopedics, Inc.199963—
+2K152968Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201583—
+2K120899Range Spinal System, Unit RodK2m, Inc.201235—
+2K111942TSRH Spinal SystemsMedtronic Sofamor Danek USA, Inc.2011242—
+2K103671Genesys Spine Tilock SystemGenesys Spine20118—
+2K103049TSRH Spinal SystemMedtronic Sofamor Danek2010244—
+2K100788Cocr RodsGlobus Medical, Inc.2010374—
+2K090740Modification to: TSRH Spinal SystemMedtronic Sofamor Danek20091—
+2K081080TSRH Spinal SystemMedtronic Sofamor Danek2008614—
+2K073430Valeo Pedicle Screw Spinal SystemAmedica Corp.200824—
+2K043001MX Polyaxial Pedicle ScrewScient'X200437—
+2K023299Alpha Mirage Top Tightening Spinal SystemAlphatec Mfg., Inc.20020—
+2K001080Spine System EvolutionAesculap, Inc.200062—
+3K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+3K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+3K190567KeYi Spinal Fixation SystemBeijing Keyi Medical Device Technology Co., Ltd.20190—
+3K181995Chiral Surgical Pedicle Screw SystemChiral Surgical20180—
+3K181677Kodiak Spinal Fixation SystemAlphatec Spine, Inc.201870—
+3K180153X-spine Cortical Bone Screw SystemX-Spine Systems, Inc.20180—
+3K173131Rexious Spinal Fixation SystemHuvexel Co., Ltd.20175—
+3K172469TiLock Modular Spinal SystemGenesys Spine20170—
+3K171838TiLock2 Spinal SystemGenesys Spine20174—
+3K170266Palisade™ Pedicular Fixation SystemSpineology, Inc.20172—
+3K170255Threshold™ V2 Pedicular Fixation SystemSpineology, Inc.20171—
+3K170251Threshold™ Pedicular Fixation SystemSpineology, Inc.20171—
+3K170268Fortress™ Pedicular Fixation SystemSpineology, Inc.20171—
+3K162160Preference Elite Pedicle Screw SystemAmedica Corporation20161—
+3K161914Genesys Spine TiLock Cortical Spinal SystemGenesys Spine20161—
+3K161363Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201675—
+3K151704Diplomat® Spinal SystemSignus Medizintechnik GmbH20164—
+3K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+3K152039Genesys Spine TiLock2 Spinal SystemGenesys Spine20157—
+3K143230Palladian Lumbar Pedicle Screw SystemNeurostructures, Inc.20150—
+3K141282PGS 5.5 MM Cannulated Pedicle ScrewPinnacle Spine Group20141—
+3K140238Excella Iii-D Spinal Deformity SystemInnovasis, Inc.201432
+3K133287Presson Spinal Fixation SystemNexus Spine, LLC20141—
+3K131030Range Spinal SystemK2m, Inc.201334—
+3K122877Range Spinal System, Small StatureK2m, Inc.201334—
+3K123138Pass LP Spinal SystemMedicrea International2013132—
+3K121670Medyssey Cannulated Pedicle ScrewMedyssey Co, Ltd.201311—
+3K123352S4 Spinal SystemAesculap Implant Systems, Inc.201251—
+3K122226Revere Stabilization SystemGlobus Medical, Inc.2012225—
+3K121630Range Spinal SystemK2m, Inc.2012127—
+3K121922Beacon Stabilization SystemGlobus Medical, Inc.20129—
+3K113395Revere 4.5 Stabilization SystemGlobus Medical, Inc.2012260—
+3K112551S4 Spinal SystemAesculap Implant System, Inc.201161—
+3K111449Revolve Additional ImplantsGlobus Medical, Inc.2011236—
+3K111479Revere CrosstopGlobus Medical, Inc.2011232—
+3K110963Ellipse Occipito-Cervico-Thoracic Spinal SystemGlobus Medical, Inc.201198—
+3K102488Apex Spine System W/ Cocr RodsSpinecraft, LLC2010177—
+3K091797TSRH Spinal SystemMedtronic Sofamor Danek2010606—
+3K092676TSRH Spinal SystemMedtronic Sofamor Danek, Inc.20090—
+3K080767Conquest Spinal SystemLife Spine200821—
+3K062912Scient'x Spinal SystemScient'X200736—
+4K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+4K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+4K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+4K252322SIros-X SystemGenesys Spine20250—
+4K243281LOCK-IN Spinal Fixation SystemLock-In USA Corp20240—
+4K241276Vector™ Pedicle Screw SystemInnovasis, Inc.202411
+4K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+4K232218Zenius™ Spinal SystemMedyssey USA, Inc.20230—
+4K222415Rexious Spinal Fixation SystemDio Medical Corporation20221—
+4K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+4K220285PINE Pedicle Screw SystemTdm Co., Ltd.20220—
+4K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+4K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+4K212185Golden Isles Pedicle Screw SystemIntelivation, LLC20210—
+4K211957QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.20213—
+4K210420Goblin and Goblin LS Pedicle Screw SystemsMedynus, Inc.20211—
+4K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+4K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+4K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+4K201427Trivergent Spinal Fixation SystemBenvenue Medical, Inc.20202—
+4K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+4K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+4K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+4K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+4K181139OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20188—
+4K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+4K180458FOCUS Pedicle Screw SystemNvision Biomedical Technologies, LLC20181—
+4K180324Patriot Spinal Fixation SystemValorus Spine20180—
+4K180210CREO® Stabilization SystemGlobus Medical, Inc.201888—
+4K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180—
+4K173508Everest Spinal SystemK2m20189—
+4K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+4K171321K2M Navigation InstrumentsK2m201711
+4K171526Zenius™, lliad™ and Kora™ Spinal Fixation SystemsMedyssey USA, Inc.20172—
+4K172107Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™…Spineology, Inc.20170—
+4K171651Excelsius GPSGlobus Medical, Inc.2017691
+4K171438Palisade™ Pedicular Fixation SystemSpineology, Inc.20171—
+4K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+4K162143FixxSure® X-LinkInnovasis, Inc.20160—