510(k) Report

Devices descending from K021009

184 later devices reach Octafix Occipital Cervical Plating System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K090060Nexlink Oct System, Model 7000 SeriesAbbott Spine, Inc.20098—
+1K062505Nex-Link Spinal Fixation System Offset Connectors, 2121-XX SeriesAbbott Spine, Inc.20063—
+1K052402Vertex Reconstruction SystemMedtronic Sofamor Danek2005180—
+2K180851VERTEX™ Reconstruction SystemMedtronic Sofamor Danek USA, Inc.20188—
+2K171444YUKON OCT Spinal SystemK2m, Inc.2017133
+2K142752Minit Posterior Cervical-Thoracic Fixation System, Nex-Link Spinal Fixation System…Zimmer Spine, Inc.20150—
+2K133288Caspian Oct Spinal SystemK2m, Inc.201418—
+2K121877Gibralt Occipital Plate Screws, Set Screw, Gibralt Occipital System Articulating Rod…Exactech, Inc.20134—
+2K113346Neon SystemUlrich GmbH & Co. KG20121—
+2K071942Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek200724—
+2K070742Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek2007150—
+2K062879Traverse Oct Spinal Fixation SystemMedtronic Sofamor Danek, Inc.2006151—
+2K052734Modification to: Vertex Reconstruction SystemMedtronic Sofamor Danek2005175—
+3K253195TAURUS Posterior Occipital-Cervico-Thoracic Spinal SystemsZheJiang Decans Medical Devices Co., Ltd.20260—
+3K230614Cortium™Ulrich Medical USA20230—
+3K222107Black Diamond™ POCT Spinal SystemOsseus Fusion Systems20220—
+3K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+3K192646SYMPHONY™ OCT SystemMedos International SARL20202—
+3K193129Yukon OCT Spinal SystemK2m, Inc.202001
+3K182182YUKON OCT Spinal SystemK2m20185—
+3K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+3K163375INFINITY™ OCT SystemMedtronic Sofamor Danek USA, Inc.2017165
+3K153370Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m, Incorporated201617—
+3K133374Streamline Oct Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Rti Surgical, I20143—
+3K121979Pass Oct Spinal SystemMedicrea International201314—
+3K123656Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc.201339—
+3K110522Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc.2011106—
+3K093434Vertex Reconstruction System and Vertex Select Reconstruction SystemMedtronic Sofamor Danek20097—
+3K091365Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Soafamor Danek2009138—
+3K073420Blackstone Ascent Multiaxial ScrewsBlackstone Medical, Inc.20089—
+3K062934SierraSeaspine, Inc.200621—
+4K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+4K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+4K254165Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20260—
+4K253129Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20250—
+4K251725ANAX™ OCT Spinal SystemCg Medtech Co., Ltd.20250—
+4K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+4K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+4K233366SYMPHONY OCT SystemMedos International SARL20230—
+4K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+4K223764INFINITY OCT SystemMedtronic Sofamor Danek USA, Inc.20230—
+4K220810Infinity™ OCT System and PASS OCT Spinal SystemMedicrea International20220—
+4K210449Infinity™ OCT System, PASS OCT® Spinal SystemMedtronic20213—
+4K203319SYMPHONY™ OCT SystemMedos International SARL20211—
+4K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+4K181350ASTRA-OCT Spine SystemSpinecraft, LLC20180—
+4K161032neon3™ universal OCT spinal stabilizationUlrich GmbH & Co. KG201671
+4K150918PASS OCT Spinal SystemMedicrea International SA201513—
+4K150254Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)201523
+4K140734Nextgen Altius Oct SystemEbi, LLC20140—
+4K133556Virage Oct Spinal Fixation SystemZimmer Spine, Inc.2014272
+4K133698Synapse SystemSynthes USA Products, LLC20146—
+4K122163Certex Spinal Implant SystemX-Spine Systems, Inc.20122—
+4K122378Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC)201271
+4K120467Spinal Elements Posterior Cervical/Thoracic Spinal SystemSpinal Elements, Inc.20121—
+4K113593Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC)2012102—
+4K111076Solanas Avalon Posterior Fixation SystemAlphatec Spine, Inc.20115—
+4K072729SierraSeaspine, Inc.20085—
+4K080526Sierra SystemSeaspine, Inc.20089—
+5K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+5K253545Vulcan Spinal SystemK2m, Inc.20260—
+5K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+5K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+5K233078Posterior Cervical Spine SystemDouble Medical Technology, Inc.20231—
+5K231654NorthStar OCT SystemSeaspine, Inc.20230—
+5K221307Edge Upper Cervical SystemSpinal Simplicity, LLC20230—
+5K200571PERLA® Posterior Occipito-Cervico-Thoracic Fixation SystemSpineart20200—
+5K193615NorthStar™ OCT Spinal SystemSeaSpine Orthopedics Corporation20201—
+5K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+5K182837M.U.S.T. Mini ExtensionMedacta International S.A.20191—
+5K173522Solanas® Posterior Stabilization SystemAlphatec Spine, Inc.20175—
+5K162266The Cranial Fusion SystemLife Spine, Inc.20171—
+5K162575Z-LINKPC SystemZavation, LLC20173—
+5K161498Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20161—
+5K161149PASS OCT Spinal SystemMedicrea International SA20160—
+5K160428Certex Spinal Fixation SystemX-Spine Systems, Inc.20160—
+5K160756PASS OCT Spinal SystemMedicrea International SA20160—
+5K153169PASS OCT Patient Specific RodsMedicrea International20164—
+5K141897Synapse System, Synthes OC Fusion SystemSynthes USA Products, LLC20145—
+5K141284Caspian Spinal SystemK2m, Inc.20140—
+5K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014671
+5K131833Centurion Poct SystemOrthofix, Inc.20142—
+5K133094Certex Oct Spinal Implant SystemX-Spine Systems, Inc.20131—
+5K131427LOTUSSpinal Elements, Inc.20130—
+5K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC)2013752
+5K121725Pioneer Posterior Occipito-Cervico-Thoracic (Oct) SystemPioneer Surgical Technology, Inc.201217—
+5K120998Solstice Cross ConnectorLife Spine20121—
+5K112025Sure Lok Mini Posterior Cervical/Upper Thoracic SystemSpinal USA20114—
+6K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+6K250866Sovereign Posterior Cervical SystemMet One Technologies, LLC20251—
+6K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+6K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+6K231811Zavation Connector SystemZavation Medical Products, LLC20230—
+6K203149M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20200—
+6K200896Solstice CCILife Spine, Inc.20200—
+6K191185Solanas® Posterior OCT Fixation SystemAlphatec Spine20194—
+6K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+6K172139Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20170—
+6K171369M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20178—
+6K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—