510(k) Report

Devices descending from K062254

222 later devices reach Axis Fixation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K143471VERTEX Reconstruction SystemMedtronic Sofamor Danek USA, Inc.2015165—
+1K142838Synapse Occipital-Cervical-Thoracic (OCT) SystemSynthes USA Products, LLC20151921
+2K250866Sovereign Posterior Cervical SystemMet One Technologies, LLC20251—
+2K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+2K233078Posterior Cervical Spine SystemDouble Medical Technology, Inc.20231—
+2K203319SYMPHONY™ OCT SystemMedos International SARL20211—
+2K203149M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20200—
+2K200571PERLA® Posterior Occipito-Cervico-Thoracic Fixation SystemSpineart20200—
+2K192646SYMPHONY™ OCT SystemMedos International SARL20202—
+2K200130M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20206—
+2K182837M.U.S.T. Mini ExtensionMedacta International S.A.20191—
+2K182508Saxxony™ Posterior Cervical Thoracic SystemNexxt Spine, LLC20184—
+2K181949SYMPHONY™ OCT SystemMedos International SARL201810—
+2K181350ASTRA-OCT Spine SystemSpinecraft, LLC20180—
+2K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated20184—
+2K171834G Surgical OCT Spinal SystemG Surgical, LLC20170—
+2K172594Proficient® Posterior Cervical Spine SystemSpine Wave, Inc.201712—
+2K171250BRIDALVEIL Occipital Cervical Thoracic SystemAstura Medical20171—
+2K163375INFINITY™ OCT SystemMedtronic Sofamor Danek USA, Inc.2017165
+2K172139Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20170—
+2K171444YUKON OCT Spinal SystemK2m, Inc.2017133
+2K171369M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20178—
+2K170804The Solstice OCT SystemLife Spine, Inc.20173—
+2K162575Z-LINKPC SystemZavation, LLC20173—
+2K162639Proficient™ Posterior Cervical Spine SystemSpine Wave, Inc.201713—
+2K161637Poseidon OCT Spinal Fixation SystemMedyssey USA, Inc.20170—
+2K161032neon3™ universal OCT spinal stabilizationUlrich GmbH & Co. KG201671
+2K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.201678—
+2K161498Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20161—
+2K153439PathLoc-C Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd.20160—
+2K161149PASS OCT Spinal SystemMedicrea International SA20160—
+2K160697Gibralt® Spine System and Gibralt® Occipital Spine SystemExactech, Inc.20165—
+2K160756PASS OCT Spinal SystemMedicrea International SA20160—
+2K153386Perla Posterior Cervico-Thoracic Fixation systemSpineart20162—
+2K152211PCT SystemCentinel Spine, Inc.20150—
+2K152338VERTEX (r) Reconstruction SystemMedtronic Sofamor Danek USA, Inc.201534—
+2K151938S4 Cervical Spinal and Occiput SystemsAesculap Implant Systems, LLC20152—
+2K150474NuVasive VuePoint II OCT SystemNu Vasive, Incorporated201526—
+2K150918PASS OCT Spinal SystemMedicrea International SA201513—
+2K150650neon3Ulrich GmbH & Co. KG2015101
+2K151885SUMMIT SI OCT Spinal Fixation System, MOUNTAINEER OCT Spinal SystemDepuy Synthes, Inc.201541—
+2K151705Lotus Posterior Cervical/Thoracic Spinal SystemSpinal Elements, Inc.20150—
+2K151224Lineum OCT Spine SystemBiomet Spine2015231
+2K151031Virage OCT Spinal Fixation SystemZimmer Spine, Inc.201520—
+2K150552ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMSGlobus Medical, Inc.2015961
+2K150570ANAX OCT Spinal SystemU&I Corporation20152—
+2K150822Centurion POCT SystemOrthofix, Inc.201523—
+2K150539OASYS SystemStryker Corporation201534—
+3K254260The VEGA Cervical Screw SystemGS Medical Co., Ltd.20260—
+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—
+3K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+3K253129Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20250—
+3K251725ANAX™ OCT Spinal SystemCg Medtech Co., Ltd.20250—
+3K242674Freedom Posterior Cervical ScrewsSignature Orthopaedics Pty, Ltd.20250—
+3K242516EUROPA™ Posterior Cervical Fusion SystemMiRus, LLC20242—
+3K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+3K233332Statera-C™ Spinal SystemK&J Consulting Corp.20230—
+3K233366SYMPHONY OCT SystemMedos International SARL20230—
+3K231811Zavation Connector SystemZavation Medical Products, LLC20230—
+3K221307Edge Upper Cervical SystemSpinal Simplicity, LLC20230—
+3K230614Cortium™Ulrich Medical USA20230—
+3K223764INFINITY OCT SystemMedtronic Sofamor Danek USA, Inc.20230—
+3K220658COSY Cervicothoracic Occipital Rod-Screw SystemSignus Medizintechnik GmbH20220—
+3K222107Black Diamond™ POCT Spinal SystemOsseus Fusion Systems20220—
+3K213871Ennovate Cervical Spinal and Occiput SystemAesculap Implant Systems, LLC20220—
+3K220570M.U.S.T. MINI Posterior Cervical Screws System ExtensionMedacta International S.A.20220—
+3K220810Infinity™ OCT System and PASS OCT Spinal SystemMedicrea International20220—
+3K220025ARx® Spinal SystemLife Spine, Inc.20220—
+3K213654NuVasive Reline Cervical SystemNu Vasive, Incorporated20221—
+3K211957QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.20213—
+3K211993Z-LINKPC SystemZavation Medical Products, LLC20210—
+3K210449Infinity™ OCT System, PASS OCT® Spinal SystemMedtronic20213—
+3K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+3K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+3K200896Solstice CCILife Spine, Inc.20200—
+3K192013VERTICALE® Cervical SystemSilony Medical GmbH20202—
+3K193129Yukon OCT Spinal SystemK2m, Inc.202001
+3K192014SYPMHONY™ OCT SystemMedos International SARL20203—
+3K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+3K192354Innovasis Gibralt Spine SystemInnovasis, Inc.20190—
+3K191553NuVaisve® Reline® Cervical SystemNu Vasive, Incorporated20192—
+3K190895MOUNTAINEER OCT Spinal System, SUMMIT SI OCT Spinal Fixation System, SYMPHONY OCT…Medos International SARL20199—
+3K190071Perla® Posterior Cervico-Thoracic Fixation SystemSpineart20191—
+3K183383ANAX™ OCT Spinal SystemU&I Corporation20181—
+3K182954Salvo™ Spine SystemSpine Wave, Inc.20186—
+3K182182YUKON OCT Spinal SystemK2m20185—
+3K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+3K181440Proficient® Posterior Cervical Spine SystemSpine Wave, Inc.20184—
+3K180690Navigation InstrumentsGlobus Medical, Inc.20189—
+3K180851VERTEX™ Reconstruction SystemMedtronic Sofamor Danek USA, Inc.20188—
+3K173047The Solstice OCT SystemLife Spine, Inc.20180—
+3K180025Centurion POCT SystemOrthofix, Inc.20186—
+3K173522Solanas® Posterior Stabilization SystemAlphatec Spine, Inc.20175—
+3K172279PMT Posterior Fixation SystemProvidence Medical Technology, Inc.20170—
+3K171651Excelsius GPSGlobus Medical, Inc.2017691
+3K170647Connector SystemOrthofix, Inc.201718—
+3K162266The Cranial Fusion SystemLife Spine, Inc.20171—
+3K162300Reform® POCT SystemPrecision Spine, Inc.20162—