510(k) Report

Devices descending from K103100

184 later devices reach Mountaineer Oct Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K181350ASTRA-OCT Spine SystemSpinecraft, LLC20180—
+1K113593Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC)2012102—
+1K110963Ellipse Occipito-Cervico-Thoracic Spinal SystemGlobus Medical, Inc.201198—
+2K211957QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.20213—
+2K150552ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMSGlobus Medical, Inc.2015961
+2K140734Nextgen Altius Oct SystemEbi, LLC20140—
+2K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014671
+2K123783Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol ImplantsGlobus Medical, Inc.201397—
+2K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC)2013752
+2K121725Pioneer Posterior Occipito-Cervico-Thoracic (Oct) SystemPioneer Surgical Technology, Inc.201217—
+2K120998Solstice Cross ConnectorLife Spine20121—
+2K122378Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC)201271
+3K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+3K233332Statera-C™ Spinal SystemK&J Consulting Corp.20230—
+3K200571PERLA® Posterior Occipito-Cervico-Thoracic Fixation SystemSpineart20200—
+3K182508Saxxony™ Posterior Cervical Thoracic SystemNexxt Spine, LLC20184—
+3K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+3K171651Excelsius GPSGlobus Medical, Inc.2017691
+3K171369M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20178—
+3K162575Z-LINKPC SystemZavation, LLC20173—
+3K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+3K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.201678—
+3K153370Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m, Incorporated201617—
+3K152211PCT SystemCentinel Spine, Inc.20150—
+3K151974Polaris Spinal SystemBiomet Spine201516—
+3K150896Vitality Spinal Fixation SystemZimmer Spine, Inc.2015193
+3K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+3K150229SOLSTICE OCT SystemLife Spine, Inc.20150—
+3K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+3K141284Caspian Spinal SystemK2m, Inc.20140—
+3K140123Polaris Spinal System -Translation ScrewEbi, LLC2014221
+3K133374Streamline Oct Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Rti Surgical, I20143—
+3K131833Centurion Poct SystemOrthofix, Inc.20142—
+3K132504Tiger Occipital-Cervical-Thoracic Spinal Fixation SystemCorelink, LLC20132—
+3K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)201370—
+4K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+4K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+4K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+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—
+4K250866Sovereign Posterior Cervical SystemMet One Technologies, LLC20251—
+4K242674Freedom Posterior Cervical ScrewsSignature Orthopaedics Pty, Ltd.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—
+4K242516EUROPA™ Posterior Cervical Fusion SystemMiRus, LLC20242—
+4K240160EGPS Navigated InstrumentsAstura Medical20240—
+4K230325GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal SystemGreens Surgicals Pvt., Ltd.20240—
+4K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+4K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+4K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+4K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+4K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+4K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+4K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+4K231811Zavation Connector SystemZavation Medical Products, LLC20230—
+4K223558CUVIS-spineCurexo, Inc.20230—
+4K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+4K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+4K220570M.U.S.T. MINI Posterior Cervical Screws System ExtensionMedacta International S.A.20220—
+4K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+4K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+4K201569CUVIS-spineCurexo, Inc.20212—
+4K210275Polaris Spinal SystemZimmer Biomet Spine, Inc.20210—
+4K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+4K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+4K203149M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20200—
+4K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+4K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+4K200303Reform Pedicle Screw SystemPrecision Spine202010—
+4K200863Tiger® Occipital-Cervical-Thoracic Spinal Fixation SystemCorelink, LLC20200—
+4K200130M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20206—
+4K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+4K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+4K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+4K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+4K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+4K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+4K182837M.U.S.T. Mini ExtensionMedacta International S.A.20191—
+4K183080Mega Plus Spine SystemBk Meditech, Co., Ltd.20182—
+4K182182YUKON OCT Spinal SystemK2m20185—
+4K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+4K180690Navigation InstrumentsGlobus Medical, Inc.20189—
+4K180433Ennovate®Aesculap Implant Systems, LLC201811
+4K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179—
+4K171444YUKON OCT Spinal SystemK2m, Inc.2017133
+4K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.20170—
+4K171907Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc.2017162
+4K162266The Cranial Fusion SystemLife Spine, Inc.20171—
+4K150856Reform Pedicle Screw SystemPrecision Spine, Inc.201526—
+4K150254Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)201523
+4K141804Polaris Spinal System - HA CoatedBiomet Spine, LLC201421—
+5K254260The VEGA Cervical Screw SystemGS Medical Co., Ltd.20260—
+5K260369Dynamis Robotic Surgical SystemLEM Surgical AG20260—
+5K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+5K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+5K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+5K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—