510(k) Report

Devices descending from K042508

301 later devices reach Sumit Oct Spinal System and Mountaineer Oct Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K203149M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20200—
+1K200130M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20206—
+1K193129Yukon OCT Spinal SystemK2m, Inc.202001
+1K182837M.U.S.T. Mini ExtensionMedacta International S.A.20191—
+1K181350ASTRA-OCT Spine SystemSpinecraft, LLC20180—
+1K171444YUKON OCT Spinal SystemK2m, Inc.2017133
+1K132332Mountaineer Oct Spinal SystemMedos International SARL20134—
+1K121979Pass Oct Spinal SystemMedicrea International201314—
+1K121877Gibralt Occipital Plate Screws, Set Screw, Gibralt Occipital System Articulating Rod…Exactech, Inc.20134—
+1K121725Pioneer Posterior Occipito-Cervico-Thoracic (Oct) SystemPioneer Surgical Technology, Inc.201217—
+1K122378Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC)201271
+1K113593Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC)2012102—
+1K110353Mountaineer Oct Spinal SystemDepuy Spine, Inc.2011156—
+1K103232Caspian Spinal SystemK2m, Inc.201146—
+1K092656Lanx Posterior Cervicothoracic Spinal Fixation SystemLanx, Inc.20095—
+1K083073Theken Atoll Cervico-Thoracic SystemTheken Spine, LLC20098—
+1K080828Mountaineer Oct Spinal SystemDepuy Spine, Inc.2008242—
+1K073420Blackstone Ascent Multiaxial ScrewsBlackstone Medical, Inc.20089—
+1K073654Blackstone Ascent Poct System Parallel Rod ConnectorBlackstone Medical, Inc.2008129—
+1K071905Posterior Cervicothoracic Spinal Fixation System (PCFS)Lanx, LLC20076—
+1K062934SierraSeaspine, Inc.200621—
+2K222107Black Diamond™ POCT Spinal SystemOsseus Fusion Systems20220—
+2K220570M.U.S.T. MINI Posterior Cervical Screws System ExtensionMedacta International S.A.20220—
+2K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+2K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+2K200571PERLA® Posterior Occipito-Cervico-Thoracic Fixation SystemSpineart20200—
+2K182182YUKON OCT Spinal SystemK2m20185—
+2K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+2K173047The Solstice OCT SystemLife Spine, Inc.20180—
+2K171250BRIDALVEIL Occipital Cervical Thoracic SystemAstura Medical20171—
+2K171369M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20178—
+2K162575Z-LINKPC SystemZavation, LLC20173—
+2K161032neon3™ universal OCT spinal stabilizationUlrich GmbH & Co. KG201671
+2K152211PCT SystemCentinel Spine, Inc.20150—
+2K150918PASS OCT Spinal SystemMedicrea International SA201513—
+2K150254Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)201523
+2K140734Nextgen Altius Oct SystemEbi, LLC20140—
+2K141284Caspian Spinal SystemK2m, Inc.20140—
+2K133374Streamline Oct Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Rti Surgical, I20143—
+2K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014671
+2K131833Centurion Poct SystemOrthofix, Inc.20142—
+2K133698Synapse SystemSynthes USA Products, LLC20146—
+2K132504Tiger Occipital-Cervical-Thoracic Spinal Fixation SystemCorelink, LLC20132—
+2K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC)2013752
+2K122163Certex Spinal Implant SystemX-Spine Systems, Inc.20122—
+2K122292Reliance Posterior Cervical- Thoracic SystemReliance Medical Systems, LLC20124—
+2K120998Solstice Cross ConnectorLife Spine20121—
+2K120467Spinal Elements Posterior Cervical/Thoracic Spinal SystemSpinal Elements, Inc.20121—
+2K121808Casian, 3.5/4.5 ConnectorsK2m, Inc.20121—
+2K120656Everest Spinal SystemK2m, Inc.201243—
+2K113346Neon SystemUlrich GmbH & Co. KG20121—
+2K113654CaspianK2m, Inc.201244—
+2K113434Lanx Posterior Cervicothoracic Spinal Fixation System (PCFS)Lanx, Inc.20111—
+2K103040Lanx Posterior Cervicothoracic Spinal Fixation System (PCFS)Lanx, LLC20112—
+2K103100Mountaineer Oct Spinal SystemDepuy Spine, Inc.2010184—
+2K100888Modification to Lanx Posterior Cervicothoracic Spinal Fixation SystemLanx, Inc.20103—
+2K093319Nuvasive Vuepoint Oct SystemNuvasive, Inc.201010—
+2K100191Lanx Posterior Cervicothoracic Spinal Fixation System (PCFS)Lanx, Inc.20103—
+2K091359Gso PCT Spinal SystemGold Standard Orthopaedics, LLC20090—
+2K083863Theken Atoll Oct Spinal SystemTheken Spine, LLC200921—
+2K072729SierraSeaspine, Inc.20085—
+2K080526Sierra SystemSeaspine, Inc.20089—
+2K080394Blackstone Ascent Posterior Occipital Cervico-Thoracic (Poct) SystemBlackstone Medical, Inc.2008124—
+3K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+3K250866Sovereign Posterior Cervical SystemMet One Technologies, LLC20251—
+3K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+3K231811Zavation Connector SystemZavation Medical Products, LLC20230—
+3K231654NorthStar OCT SystemSeaspine, Inc.20230—
+3K221307Edge Upper Cervical SystemSpinal Simplicity, LLC20230—
+3K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+3K230614Cortium™Ulrich Medical USA20230—
+3K213654NuVasive Reline Cervical SystemNu Vasive, Incorporated20221—
+3K213394Vy Spine™ VySpan™ PCT SystemVy Spine, LLC20212—
+3K210887Altus Spine Sochi OCT Spinal SystemAltus Partners, LLC20210—
+3K200863Tiger® Occipital-Cervical-Thoracic Spinal Fixation SystemCorelink, LLC20200—
+3K193615NorthStar™ OCT Spinal SystemSeaSpine Orthopedics Corporation20201—
+3K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+3K191553NuVaisve® Reline® Cervical SystemNu Vasive, Incorporated20192—
+3K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated20184—
+3K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+3K173522Solanas® Posterior Stabilization SystemAlphatec Spine, Inc.20175—
+3K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+3K161498Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20161—
+3K161149PASS OCT Spinal SystemMedicrea International SA20160—
+3K160428Certex Spinal Fixation SystemX-Spine Systems, Inc.20160—
+3K160756PASS OCT Spinal SystemMedicrea International SA20160—
+3K153169PASS OCT Patient Specific RodsMedicrea International20164—
+3K151974Polaris Spinal SystemBiomet Spine201516—
+3K150896Vitality Spinal Fixation SystemZimmer Spine, Inc.2015193
+3K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+3K142867Reliance Posterior Cervical-Thoracic SystemReliance Medical Systems, LLC20153—
+3K142253SOLSTICE OCT SystemLife Spine, Inc.20153—
+3K150229SOLSTICE OCT SystemLife Spine, Inc.20150—
+3K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.201513—
+3K142558Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m20140—
+3K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+3K141897Synapse System, Synthes OC Fusion SystemSynthes USA Products, LLC20145—
+3K140529Everest Spinal SystemK2m, LLC201431—
+3K140123Polaris Spinal System -Translation ScrewEbi, LLC2014221
+3K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—