510(k) Report

Devices descending from K062879

151 later devices reach Traverse Oct Spinal Fixation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K070742Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek2007150—
+2K180851VERTEX™ Reconstruction SystemMedtronic Sofamor Danek USA, Inc.20188—
+2K163375INFINITY™ OCT SystemMedtronic Sofamor Danek USA, Inc.2017165
+2K123656Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc.201339—
+2K110522Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc.2011106—
+2K093434Vertex Reconstruction System and Vertex Select Reconstruction SystemMedtronic Sofamor Danek20097—
+2K073420Blackstone Ascent Multiaxial ScrewsBlackstone Medical, Inc.20089—
+3K253195TAURUS Posterior Occipital-Cervico-Thoracic Spinal SystemsZheJiang Decans Medical Devices Co., Ltd.20260—
+3K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+3K254165Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20260—
+3K253129Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20250—
+3K251725ANAX™ OCT Spinal SystemCg Medtech Co., Ltd.20250—
+3K223764INFINITY OCT SystemMedtronic Sofamor Danek USA, Inc.20230—
+3K220810Infinity™ OCT System and PASS OCT Spinal SystemMedicrea International20220—
+3K210449Infinity™ OCT System, PASS OCT® Spinal SystemMedtronic20213—
+3K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+3K192646SYMPHONY™ OCT SystemMedos International SARL20202—
+3K181350ASTRA-OCT Spine SystemSpinecraft, LLC20180—
+3K161032neon3™ universal OCT spinal stabilizationUlrich GmbH & Co. KG201671
+3K140734Nextgen Altius Oct SystemEbi, LLC20140—
+3K133556Virage Oct Spinal Fixation SystemZimmer Spine, Inc.2014272
+3K121877Gibralt Occipital Plate Screws, Set Screw, Gibralt Occipital System Articulating Rod…Exactech, Inc.20134—
+3K122378Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC)201271
+3K113593Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC)2012102—
+3K113346Neon SystemUlrich GmbH & Co. KG20121—
+3K111076Solanas Avalon Posterior Fixation SystemAlphatec Spine, Inc.20115—
+4K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+4K233078Posterior Cervical Spine SystemDouble Medical Technology, Inc.20231—
+4K233366SYMPHONY OCT SystemMedos International SARL20230—
+4K221307Edge Upper Cervical SystemSpinal Simplicity, LLC20230—
+4K230614Cortium™Ulrich Medical USA20230—
+4K203319SYMPHONY™ OCT SystemMedos International SARL20211—
+4K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+4K200571PERLA® Posterior Occipito-Cervico-Thoracic Fixation SystemSpineart20200—
+4K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+4K182837M.U.S.T. Mini ExtensionMedacta International S.A.20191—
+4K182182YUKON OCT Spinal SystemK2m20185—
+4K171444YUKON OCT Spinal SystemK2m, Inc.2017133
+4K162266The Cranial Fusion SystemLife Spine, Inc.20171—
+4K162575Z-LINKPC SystemZavation, LLC20173—
+4K150918PASS OCT Spinal SystemMedicrea International SA201513—
+4K150254Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)201523
+4K141284Caspian Spinal SystemK2m, Inc.20140—
+4K133374Streamline Oct Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Rti Surgical, I20143—
+4K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014671
+4K131833Centurion Poct SystemOrthofix, Inc.20142—
+4K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC)2013752
+4K121725Pioneer Posterior Occipito-Cervico-Thoracic (Oct) SystemPioneer Surgical Technology, Inc.201217—
+4K120998Solstice Cross ConnectorLife Spine20121—
+5K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+5K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+5K250866Sovereign Posterior Cervical SystemMet One Technologies, LLC20251—
+5K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+5K231811Zavation Connector SystemZavation Medical Products, LLC20230—
+5K222107Black Diamond™ POCT Spinal SystemOsseus Fusion Systems20220—
+5K203149M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20200—
+5K200896Solstice CCILife Spine, Inc.20200—
+5K193129Yukon OCT Spinal SystemK2m, Inc.202001
+5K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+5K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+5K173522Solanas® Posterior Stabilization SystemAlphatec Spine, Inc.20175—
+5K171369M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20178—
+5K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+5K161498Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20161—
+5K161149PASS OCT Spinal SystemMedicrea International SA20160—
+5K160756PASS OCT Spinal SystemMedicrea International SA20160—
+5K153169PASS OCT Patient Specific RodsMedicrea International20164—
+5K152211PCT SystemCentinel Spine, Inc.20150—
+5K151974Polaris Spinal SystemBiomet Spine201516—
+5K150896Vitality Spinal Fixation SystemZimmer Spine, Inc.2015193
+5K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+5K150229SOLSTICE OCT SystemLife Spine, Inc.20150—
+5K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+5K140123Polaris Spinal System -Translation ScrewEbi, LLC2014221
+5K132504Tiger Occipital-Cervical-Thoracic Spinal Fixation SystemCorelink, LLC20132—
+5K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)201370—
+6K254260The VEGA Cervical Screw SystemGS Medical Co., Ltd.20260—
+6K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+6K230325GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal SystemGreens Surgicals Pvt., Ltd.20240—
+6K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+6K220570M.U.S.T. MINI Posterior Cervical Screws System ExtensionMedacta International S.A.20220—
+6K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+6K210275Polaris Spinal SystemZimmer Biomet Spine, Inc.20210—
+6K200303Reform Pedicle Screw SystemPrecision Spine202010—
+6K200863Tiger® Occipital-Cervical-Thoracic Spinal Fixation SystemCorelink, LLC20200—
+6K200130M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20206—
+6K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+6K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+6K191185Solanas® Posterior OCT Fixation SystemAlphatec Spine20194—
+6K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+6K183080Mega Plus Spine SystemBk Meditech, Co., Ltd.20182—
+6K180433Ennovate®Aesculap Implant Systems, LLC201811
+6K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179—
+6K172139Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20170—
+6K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.20170—
+6K171907Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc.2017162
+6K150856Reform Pedicle Screw SystemPrecision Spine, Inc.201526—
+6K141804Polaris Spinal System - HA CoatedBiomet Spine, LLC201421—
+7K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+7K253545Vulcan Spinal SystemK2m, Inc.20260—