510(k) Report

Devices descending from K081195

405 later devices reach Revere Uniplanar Screws through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K121670Medyssey Cannulated Pedicle ScrewMedyssey Co, Ltd.201311—
+1K122226Revere Stabilization SystemGlobus Medical, Inc.2012225—
+1K111449Revolve Additional ImplantsGlobus Medical, Inc.2011236—
+1K110280Revlok Fenestrated Screw SystemGlobus Medical, Inc.201195—
+1K100788Cocr RodsGlobus Medical, Inc.2010374—
+1K093294Revere Stabilization SystemGlobus Medical, Inc.2010376—
+1K091782Revere 6.35 Stabilization SystemGlobus Medical, Inc.2009404—
+2K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+2K232218Zenius™ Spinal SystemMedyssey USA, Inc.20230—
+2K223273ASTRA Spine SystemSpinecraft, LLC20228—
+2K210420Goblin and Goblin LS Pedicle Screw SystemsMedynus, Inc.20211—
+2K200937ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd.20200—
+2K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+2K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+2K180210CREO® Stabilization SystemGlobus Medical, Inc.201888—
+2K172269FORTRESS™ Radiopaque Bone Cement (FORTRESS™ and FORTRESS-Plus™), CREO® Fenestrated Screw…Globus Medical, Inc.20184—
+2K173508Everest Spinal SystemK2m20189—
+2K173131Rexious Spinal Fixation SystemHuvexel Co., Ltd.20175—
+2K171526Zenius™, lliad™ and Kora™ Spinal Fixation SystemsMedyssey USA, Inc.20172—
+2K171651Excelsius GPSGlobus Medical, Inc.2017691
+2K160989NuVasive® Reline® SystemNu Vasive, Incorporated201667—
+2K151704Diplomat® Spinal SystemSignus Medizintechnik GmbH20164—
+2K141804Polaris Spinal System - HA CoatedBiomet Spine, LLC201421—
+2K140238Excella Iii-D Spinal Deformity SystemInnovasis, Inc.201432
+2K133350Revere Stabilization SystemGlobus Medical, Inc.201493—
+2K132403Annextm Adjacent Level SystemSpine Wave, Inc.20142—
+2K132603Apex Spine SystemSpinecraft, LLC201325—
+2K131878Lliad, Kora, Zenius Pedicle Screw SystemMedyssey USA, Inc.20138—
+2K124058Creo Stabilization SystemGlobus Medical, Inc.2013172—
+2K123783Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol ImplantsGlobus Medical, Inc.201397—
+2K123717UcentumUlrich GmbH & Co. KG2013171
+2K121922Beacon Stabilization SystemGlobus Medical, Inc.20129—
+2K113395Revere 4.5 Stabilization SystemGlobus Medical, Inc.2012260—
+2K111479Revere CrosstopGlobus Medical, Inc.2011232—
+2K103671Genesys Spine Tilock SystemGenesys Spine20118—
+2K110963Ellipse Occipito-Cervico-Thoracic Spinal SystemGlobus Medical, Inc.201198—
+2K103072Revere Sacral PlatesGlobus Medical, Inc.2011233—
+2K102488Apex Spine System W/ Cocr RodsSpinecraft, LLC2010177—
+3K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+3K253943Tiger 2 SystemZavation Medical Products, LLC20260—
+3K260362QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS…MANTIZ Co., Ltd.20260—
+3K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+3K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+3K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+3K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+3K241525ExcelsiusXR™Globus Medical, Inc.20250—
+3K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+3K251131Annex® 2 Adjacent Level SystemSpine Wave, Inc.20250—
+3K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+3K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+3K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+3K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+3K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+3K243281LOCK-IN Spinal Fixation SystemLock-In USA Corp20240—
+3K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+3K240160EGPS Navigated InstrumentsAstura Medical20240—
+3K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+3K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+3K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+3K241276Vector™ Pedicle Screw SystemInnovasis, Inc.202411
+3K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+3K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+3K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+3K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+3K232719ProMIS Extension Rod SystemPremia Spine, Ltd.20230—
+3K231694MASADA Modular Spinal Fixation SystemAstura Medical20232—
+3K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+3K232586Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal SystemK&J Consulting Corp.20230—
+3K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+3K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+3K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+3K223558CUVIS-spineCurexo, Inc.20230—
+3K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+3K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+3K222415Rexious Spinal Fixation SystemDio Medical Corporation20221—
+3K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+3K220285PINE Pedicle Screw SystemTdm Co., Ltd.20220—
+3K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+3K203607MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20210—
+3K211957QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.20213—
+3K212066Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20213—
+3K201569CUVIS-spineCurexo, Inc.20212—
+3K210275Polaris Spinal SystemZimmer Biomet Spine, Inc.20210—
+3K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+3K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+3K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+3K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+3K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+3K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+3K191835CREO Stabilization System, Navigation Instruments, ExcelsiusGPS InstrumentsGlobus Medical, Inc.20192—
+3K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+3K190376PASS LP Spinal SystemMedicrea International SA201915
+3K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+3K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+3K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+3K182478Whistler Modular Pedicle Screw SystemEvolution Spine, LLC20196—
+3K182954Salvo™ Spine SystemSpine Wave, Inc.20186—
+3K180498NuVasive Reline Fenestrated Screws, High V+ Bone CementNu Vasive, Incorporated201841—
+3K181978Zenius™, Iliad™ and Kora™ Spinal Fixation SystemsMedyssey USA, Inc.20180—
+3K181139OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20188—