510(k) Report

Devices descending from K111479

232 later devices reach Revere Crosstop through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K122226Revere Stabilization SystemGlobus Medical, Inc.2012225—
+1K112607Spinevision Lumis (TM) Cannulated Polyaxial Pedicle Screw Fixation System, Spinevision…Spinevision S.A.20125—
+2K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+2K180210CREO® Stabilization SystemGlobus Medical, Inc.201888—
+2K173508Everest Spinal SystemK2m20189—
+2K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A.20162—
+2K141804Polaris Spinal System - HA CoatedBiomet Spine, LLC201421—
+2K133575Spinevision Lumis Cannulated Pedicle Screw Fixation System, Spinevision U.L.I.S. Pedicle…Spinevision S.A.20143—
+2K133350Revere Stabilization SystemGlobus Medical, Inc.201493—
+2K132403Annextm Adjacent Level SystemSpine Wave, Inc.20142—
+2K130302Spinevision Lumis Cannulated Polyaxial Pedicle Screw Fixation System, Spinevision…Spinevision S.A.20134—
+2K124058Creo Stabilization SystemGlobus Medical, Inc.2013172—
+2K123783Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol ImplantsGlobus Medical, Inc.201397—
+3K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+3K251131Annex® 2 Adjacent Level SystemSpine Wave, Inc.20250—
+3K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+3K243281LOCK-IN Spinal Fixation SystemLock-In USA Corp20240—
+3K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+3K232719ProMIS Extension Rod SystemPremia Spine, Ltd.20230—
+3K231694MASADA Modular Spinal Fixation SystemAstura Medical20232—
+3K232586Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal SystemK&J Consulting Corp.20230—
+3K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+3K212066Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20213—
+3K210275Polaris Spinal SystemZimmer Biomet Spine, Inc.20210—
+3K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+3K200937ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd.20200—
+3K200267LOSPA® IS™ Spinal Fixation SystemCorentec Co., Ltd.20201—
+3K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+3K191835CREO Stabilization System, Navigation Instruments, ExcelsiusGPS InstrumentsGlobus Medical, Inc.20192—
+3K190376PASS LP Spinal SystemMedicrea International SA201915
+3K182478Whistler Modular Pedicle Screw SystemEvolution Spine, LLC20196—
+3K182954Salvo™ Spine SystemSpine Wave, Inc.20186—
+3K181139OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20188—
+3K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+3K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+3K180376K2M Patient Specific RodsK2m, Inc.20182—
+3K171651Excelsius GPSGlobus Medical, Inc.2017691
+3K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+3K150552ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMSGlobus Medical, Inc.2015961
+3K150647Polyscrew Pedicle Screw SystemNew Era Orthopedics, LLC201501
+3K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.201513—
+3K143633CREO Stabilization SystemGlobus Medical, Inc.2015158—
+3K141253New Era Orthopaedics Polyscrew Pedicle Screw SystemNew Era Orthopaedics, LLC201511
+3K133366Orthros Posterior Stabilization SystemCamber Spine20142—
+4K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+4K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+4K253545Vulcan Spinal SystemK2m, Inc.20260—
+4K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+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—
+4K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+4K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+4K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+4K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+4K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+4K240160EGPS Navigated InstrumentsAstura Medical20240—
+4K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.20240—
+4K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+4K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+4K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+4K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+4K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+4K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+4K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+4K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+4K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+4K233332Statera-C™ Spinal SystemK&J Consulting Corp.20230—
+4K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+4K230961Zeus Spinal SystemShanghai Sanyou Medical Co, Ltd.20232—
+4K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+4K231636LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20232—
+4K223558CUVIS-spineCurexo, Inc.20230—
+4K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+4K230245LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20233—
+4K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+4K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+4K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+4K220025ARx® Spinal SystemLife Spine, Inc.20220—
+4K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+4K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+4K201569CUVIS-spineCurexo, Inc.20212—
+4K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+4K200922Altus Spine HA Pedicle Screw SystemAltus Partners, LLC20213—
+4K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+4K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+4K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+4K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+4K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+4K200303Reform Pedicle Screw SystemPrecision Spine202010—
+4K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+4K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+4K191045Salvo™ Spine SystemSpine Wave, Inc.20195—
+4K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+4K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+4K182508Saxxony™ Posterior Cervical Thoracic SystemNexxt Spine, LLC20184—
+4K180980ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization SystemCamber Spine Technologies, LLC20181—
+4K181350ASTRA-OCT Spine SystemSpinecraft, LLC20180—
+4K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.201678—
+4K153370Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m, Incorporated201617—