510(k) Report

Devices descending from K093058

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K111942TSRH Spinal SystemsMedtronic Sofamor Danek USA, Inc.2011242—
+1K103671Genesys Spine Tilock SystemGenesys Spine20118—
+1K103049TSRH Spinal SystemMedtronic Sofamor Danek2010244—
+1K100788Cocr RodsGlobus Medical, Inc.2010374—
+2K190567KeYi Spinal Fixation SystemBeijing Keyi Medical Device Technology Co., Ltd.20190—
+2K181995Chiral Surgical Pedicle Screw SystemChiral Surgical20180—
+2K173131Rexious Spinal Fixation SystemHuvexel Co., Ltd.20175—
+2K172469TiLock Modular Spinal SystemGenesys Spine20170—
+2K171838TiLock2 Spinal SystemGenesys Spine20174—
+2K161914Genesys Spine TiLock Cortical Spinal SystemGenesys Spine20161—
+2K152039Genesys Spine TiLock2 Spinal SystemGenesys Spine20157—
+2K140238Excella Iii-D Spinal Deformity SystemInnovasis, Inc.201432
+2K122877Range Spinal System, Small StatureK2m, Inc.201334—
+2K123138Pass LP Spinal SystemMedicrea International2013132—
+2K121670Medyssey Cannulated Pedicle ScrewMedyssey Co, Ltd.201311—
+2K122226Revere Stabilization SystemGlobus Medical, Inc.2012225—
+2K121630Range Spinal SystemK2m, Inc.2012127—
+2K121922Beacon Stabilization SystemGlobus Medical, Inc.20129—
+2K113395Revere 4.5 Stabilization SystemGlobus Medical, Inc.2012260—
+2K111449Revolve Additional ImplantsGlobus Medical, Inc.2011236—
+2K111479Revere CrosstopGlobus Medical, Inc.2011232—
+2K110963Ellipse Occipito-Cervico-Thoracic Spinal SystemGlobus Medical, Inc.201198—
+2K102488Apex Spine System W/ Cocr RodsSpinecraft, LLC2010177—
+3K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+3K252322SIros-X SystemGenesys Spine20250—
+3K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+3K241276Vector™ Pedicle Screw SystemInnovasis, Inc.202411
+3K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+3K232218Zenius™ Spinal SystemMedyssey USA, Inc.20230—
+3K222415Rexious Spinal Fixation SystemDio Medical Corporation20221—
+3K220285PINE Pedicle Screw SystemTdm Co., Ltd.20220—
+3K211957QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.20213—
+3K210420Goblin and Goblin LS Pedicle Screw SystemsMedynus, Inc.20211—
+3K201427Trivergent Spinal Fixation SystemBenvenue Medical, Inc.20202—
+3K181139OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20188—
+3K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+3K180210CREO® Stabilization SystemGlobus Medical, Inc.201888—
+3K173508Everest Spinal SystemK2m20189—
+3K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+3K171526Zenius™, lliad™ and Kora™ Spinal Fixation SystemsMedyssey USA, Inc.20172—
+3K171651Excelsius GPSGlobus Medical, Inc.2017691
+3K162143FixxSure® X-LinkInnovasis, Inc.20160—
+3K161028K2M Growing Spine SystemK2m, Inc.20163—
+3K152148Fortress Pedicular Fixation SystemSpineology, Inc.20158—
+3K150552ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMSGlobus Medical, Inc.2015961
+3K143683APEX-DL Spine SystemSpinecraft, LLC20153—
+3K150417Astra Spine SystemSpinecraft, LLC201521—
+3K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+3K142798PASS LP Spinal SystemMedicrea International SA201584—
+3K150049PASS LP Spinal SystemMedicrea International20150—
+3K141398Pass LP Spinal SystemMedicrea International SA2015101
+3K140738Pass LP Spinal SystemMedicrea International201447—
+3K141804Polaris Spinal System - HA CoatedBiomet Spine, LLC201421—
+3K141873Range/Mesa/Denali Spinal SystemK2m, Inc.201430—
+3K140765Range/Mesa/Denali Spinal SystemK2m, Inc.201415—
+3K141147Range Spinal SystemK2m, Inc.20141—
+3K133366Orthros Posterior Stabilization SystemCamber Spine20142—
+3K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+3K133350Revere Stabilization SystemGlobus Medical, Inc.201493—
+3K132403Annextm Adjacent Level SystemSpine Wave, Inc.20142—
+3K132603Apex Spine SystemSpinecraft, LLC201325—
+3K132757Everest Spinal SystemK2m, Inc.201341—
+3K132574Pass LP Spinal SystemMedicrea International20130—
+3K132575Pass LP Spinal SystemMedicrea International20130—
+3K132644Lospa IS Pedicle Screw (Monoaxial & Polyaxial), Lospa IS Rod- Straight (Standard), Lospa…Corentec Co., Ltd.20130—
+3K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)201370—
+3K131784Range Spinal SystemK2m, Inc.201334—
+3K131878Lliad, Kora, Zenius Pedicle Screw SystemMedyssey USA, Inc.20138—
+3K130932Firebird Spinal Fixation SystemOrthofix, Inc.2013811
+3K124058Creo Stabilization SystemGlobus Medical, Inc.2013172—
+3K130330Range Spinal SystemK2m, Inc.201336—
+3K123783Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol ImplantsGlobus Medical, Inc.201397—
+3K123412Range Spinal System, Small Strature ComponentsK2m, Inc.201334—
+3K121568Dali Spinal Fixation SystemAccel Spine20121—
+3K112607Spinevision Lumis (TM) Cannulated Polyaxial Pedicle Screw Fixation System, Spinevision…Spinevision S.A.20125—
+3K120270Venus Spinal Fixation SystemL&K BIOMED Co., Ltd.2012111—
+3K110906Apex Spine SystemSpinecraft, LLC2011103—
+4K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+4K260362QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS…MANTIZ Co., Ltd.20260—
+4K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+4K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+4K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+4K253169Duet™ Spinal Fixation SystemBox Spine, LLC20261—
+4K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+4K253545Vulcan Spinal SystemK2m, Inc.20260—
+4K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+4K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+4K241525ExcelsiusXR™Globus Medical, Inc.20250—
+4K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+4K251131Annex® 2 Adjacent Level SystemSpine Wave, Inc.20250—
+4K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+4K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+4K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+4K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+4K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+4K243281LOCK-IN Spinal Fixation SystemLock-In USA Corp20240—
+4K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+4K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+4K240160EGPS Navigated InstrumentsAstura Medical20240—
+4K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.20240—