510(k) Report

Devices descending from K080828

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K181350ASTRA-OCT Spine SystemSpinecraft, LLC20180—
+1K132332Mountaineer Oct Spinal SystemMedos International SARL20134—
+1K113593Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC)2012102—
+1K110353Mountaineer Oct Spinal SystemDepuy Spine, Inc.2011156—
+1K103100Mountaineer Oct Spinal SystemDepuy Spine, Inc.2010184—
+1K093319Nuvasive Vuepoint Oct SystemNuvasive, Inc.201010—
+1K091359Gso PCT Spinal SystemGold Standard Orthopaedics, LLC20090—
+1K083863Theken Atoll Oct Spinal SystemTheken Spine, LLC200921—
+2K213654NuVasive Reline Cervical SystemNu Vasive, Incorporated20221—
+2K210887Altus Spine Sochi OCT Spinal SystemAltus Partners, LLC20210—
+2K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+2K200571PERLA® Posterior Occipito-Cervico-Thoracic Fixation SystemSpineart20200—
+2K193615NorthStar™ OCT Spinal SystemSeaSpine Orthopedics Corporation20201—
+2K191553NuVaisve® Reline® Cervical SystemNu Vasive, Incorporated20192—
+2K182837M.U.S.T. Mini ExtensionMedacta International S.A.20191—
+2K182182YUKON OCT Spinal SystemK2m20185—
+2K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated20184—
+2K173047The Solstice OCT SystemLife Spine, Inc.20180—
+2K171444YUKON OCT Spinal SystemK2m, Inc.2017133
+2K150254Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)201523
+2K142253SOLSTICE OCT SystemLife Spine, Inc.20153—
+2K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.201513—
+2K140734Nextgen Altius Oct SystemEbi, LLC20140—
+2K133374Streamline Oct Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Rti Surgical, I20143—
+2K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014671
+2K132504Tiger Occipital-Cervical-Thoracic Spinal Fixation SystemCorelink, LLC20132—
+2K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC)2013752
+2K121877Gibralt Occipital Plate Screws, Set Screw, Gibralt Occipital System Articulating Rod…Exactech, Inc.20134—
+2K121725Pioneer Posterior Occipito-Cervico-Thoracic (Oct) SystemPioneer Surgical Technology, Inc.201217—
+2K120998Solstice Cross ConnectorLife Spine20121—
+2K122378Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC)201271
+2K121808Casian, 3.5/4.5 ConnectorsK2m, Inc.20121—
+2K120656Everest Spinal SystemK2m, Inc.201243—
+2K113654CaspianK2m, Inc.201244—
+2K110963Ellipse Occipito-Cervico-Thoracic Spinal SystemGlobus Medical, Inc.201198—
+3K231654NorthStar OCT SystemSeaspine, Inc.20230—
+3K222107Black Diamond™ POCT Spinal SystemOsseus Fusion Systems20220—
+3K221388NuVasive Reline Cervical SystemNu Vasive, Incorporated20220—
+3K220025ARx® Spinal SystemLife Spine, Inc.20220—
+3K211957QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.20213—
+3K211993Z-LINKPC SystemZavation Medical Products, LLC20210—
+3K203149M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20200—
+3K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+3K200863Tiger® Occipital-Cervical-Thoracic Spinal Fixation SystemCorelink, LLC20200—
+3K200896Solstice CCILife Spine, Inc.20200—
+3K193129Yukon OCT Spinal SystemK2m, Inc.202001
+3K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+3K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+3K171369M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20178—
+3K162266The Cranial Fusion SystemLife Spine, Inc.20171—
+3K162575Z-LINKPC SystemZavation, LLC20173—
+3K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+3K161498Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20161—
+3K152211PCT SystemCentinel Spine, Inc.20150—
+3K151974Polaris Spinal SystemBiomet Spine201516—
+3K150896Vitality Spinal Fixation SystemZimmer Spine, Inc.2015193
+3K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+3K151196Nautilus Spinal SystemLife Spine, Inc.201512—
+3K150552ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMSGlobus Medical, Inc.2015961
+3K150229SOLSTICE OCT SystemLife Spine, Inc.20150—
+3K142558Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m20140—
+3K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+3K141284Caspian Spinal SystemK2m, Inc.20140—
+3K140529Everest Spinal SystemK2m, LLC201431—
+3K140123Polaris Spinal System -Translation ScrewEbi, LLC2014221
+3K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+3K131833Centurion Poct SystemOrthofix, Inc.20142—
+3K132757Everest Spinal SystemK2m, Inc.201341—
+3K132361Everest Spinal SystemK2m, Inc.201334—
+3K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)201370—
+3K123783Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol ImplantsGlobus Medical, Inc.201397—
+4K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+4K253545Vulcan Spinal SystemK2m, Inc.20260—
+4K250866Sovereign Posterior Cervical SystemMet One Technologies, LLC20251—
+4K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+4K230325GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal SystemGreens Surgicals Pvt., Ltd.20240—
+4K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+4K233332Statera-C™ Spinal SystemK&J Consulting Corp.20230—
+4K231811Zavation Connector SystemZavation Medical Products, LLC20230—
+4K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+4K220570M.U.S.T. MINI Posterior Cervical Screws System ExtensionMedacta International S.A.20220—
+4K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+4K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+4K210275Polaris Spinal SystemZimmer Biomet Spine, Inc.20210—
+4K200303Reform Pedicle Screw SystemPrecision Spine202010—
+4K200070ARx Spinal SystemLife Spine, Inc.20209—
+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—
+4K191575ARx Spinal SystemLife Spine, Inc.201910—
+4K183430Modular Spinal Fixation SystemLife Spine, Inc.20192—
+4K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+4K183080Mega Plus Spine SystemBk Meditech, Co., Ltd.20182—
+4K182508Saxxony™ Posterior Cervical Thoracic SystemNexxt Spine, LLC20184—
+4K180433Ennovate®Aesculap Implant Systems, LLC201811
+4K173508Everest Spinal SystemK2m20189—
+4K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179—
+4K172139Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20170—
+4K171651Excelsius GPSGlobus Medical, Inc.2017691
+4K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.20170—