510(k) Report

Devices descending from K023555

381 later devices reach Modification to Vertex Reconstruction System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K123568Vertex Reconstruction SystemMedtronic Sofamor Danek USA, Inc.20120—
+1K062934SierraSeaspine, Inc.200621—
+1K042524Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek2004373—
+1K042402Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek, Inc.2004259—
+2K133698Synapse SystemSynthes USA Products, LLC20146—
+2K122163Certex Spinal Implant SystemX-Spine Systems, Inc.20122—
+2K120467Spinal Elements Posterior Cervical/Thoracic Spinal SystemSpinal Elements, Inc.20121—
+2K082728Vertex Recontruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc.2009146—
+2K083071Vertex Reconstruction SystemMedtronic Sofamor Danek20082231
+2K072729SierraSeaspine, Inc.20085—
+2K080526Sierra SystemSeaspine, Inc.20089—
+2K052376Modification to: Vertex Reconstruction SystemMedtronic Sofamor Danek2005254—
+2K050979S4 Spinal SystemAesculap, Inc.200567—
+2K050391Protex CT Cervicothoracic Spinal SystemGlobus Medical, Inc.2005148—
+2K043020Glaxy 3.2 Spinal SystemMedtronic Sofamor Danek2005108—
+3K231654NorthStar OCT SystemSeaspine, Inc.20230—
+3K211957QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.20213—
+3K193615NorthStar™ OCT Spinal SystemSeaSpine Orthopedics Corporation20201—
+3K181350ASTRA-OCT Spine SystemSpinecraft, LLC20180—
+3K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+3K163375INFINITY™ OCT SystemMedtronic Sofamor Danek USA, Inc.2017165
+3K171444YUKON OCT Spinal SystemK2m, Inc.2017133
+3K162300Reform® POCT SystemPrecision Spine, Inc.20162—
+3K160722CorticaLINK Spinal Fusion PlatformFacetlink Dba Linkspine20162—
+3K160428Certex Spinal Fixation SystemX-Spine Systems, Inc.20160—
+3K150552ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMSGlobus Medical, Inc.2015961
+3K141897Synapse System, Synthes OC Fusion SystemSynthes USA Products, LLC20145—
+3K133214Blackbird Spinal SystemChoicespine, LP20143—
+3K133094Certex Oct Spinal Implant SystemX-Spine Systems, Inc.20131—
+3K132900Marauder Cervical-Thoracic Spinal Fixation SystemIntelligent Implant Systems, LLC20130—
+3K131427LOTUSSpinal Elements, Inc.20130—
+3K123906Vertex Reconstruction System, Vertext Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc.201322—
+3K123783Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol ImplantsGlobus Medical, Inc.201397—
+3K123656Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc.201339—
+3K121877Gibralt Occipital Plate Screws, Set Screw, Gibralt Occipital System Articulating Rod…Exactech, Inc.20134—
+3K121136Renoir Posterior Cervial Fixation SystemAccel Spine20120—
+3K121191Vertex Rcconstruction SystemMedtronic Sofamor Danek, Inc.201223—
+3K120879Lexus Cervical Fixation SystemL&K BIOMED Co., Ltd.201215—
+3K113593Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC)2012102—
+3K112025Sure Lok Mini Posterior Cervical/Upper Thoracic SystemSpinal USA20114—
+3K111510CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2011128—
+3K103414Venus Cervical Spinal Fixation SystemL&K BIOMED Co., Ltd.201116—
+3K110197Exactech Gibralt Spinal SystemExactech, Inc.2011151
+3K110963Ellipse Occipito-Cervico-Thoracic Spinal SystemGlobus Medical, Inc.201198—
+3K110522Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc.2011106—
+3K101084Caspian Spinal SystemK2m, Inc.201062—
+3K093434Vertex Reconstruction System and Vertex Select Reconstruction SystemMedtronic Sofamor Danek20097—
+3K091365Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Soafamor Danek2009138—
+3K090565Ellipse Occipito-Cerico-Thoracic Spinal SystemGlobus Medical, Inc.2009101—
+3K090714Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek2009233—
+3K081906Protex CT Cervicothoracic Spinal SystemGlobus Medical, Inc.2008104—
+3K062447Traverse Oct Spinal Fixation SystemMedtronic Sofamor Danek, Inc.2007107—
+3K062327Modification to S4 Spinal SystemAesculap, Inc.200714—
+3K060152Modification to S4 Spinal SystemAesculap, Inc.200632—
+4K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+4K254165Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20260—
+4K253129Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20250—
+4K251725ANAX™ OCT Spinal SystemCg Medtech Co., Ltd.20250—
+4K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+4K233332Statera-C™ Spinal SystemK&J Consulting Corp.20230—
+4K231840CastleLoc-S Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd.20230—
+4K223764INFINITY OCT SystemMedtronic Sofamor Danek USA, Inc.20230—
+4K222107Black Diamond™ POCT Spinal SystemOsseus Fusion Systems20220—
+4K220810Infinity™ OCT System and PASS OCT Spinal SystemMedicrea International20220—
+4K220025ARx® Spinal SystemLife Spine, Inc.20220—
+4K210449Infinity™ OCT System, PASS OCT® Spinal SystemMedtronic20213—
+4K203561ChoiceSpine Navigation SystemChoice Spine, LLC20211—
+4K200793LnK Posterior Cervical Fixation System and CastleLoc-S Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd.202011—
+4K193129Yukon OCT Spinal SystemK2m, Inc.202001
+4K193465CorticaLINK Spinal Fusion PlatformSpine Smith Holdings, LLC20200—
+4K183080Mega Plus Spine SystemBk Meditech, Co., Ltd.20182—
+4K182182YUKON OCT Spinal SystemK2m20185—
+4K182508Saxxony™ Posterior Cervical Thoracic SystemNexxt Spine, LLC20184—
+4K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+4K180851VERTEX™ Reconstruction SystemMedtronic Sofamor Danek USA, Inc.20188—
+4K172495Reform® POCT SystemPrecision Spine, Inc.20181—
+4K173484CorticaLINK Spinal Fusion PlatformLinkspine, Inc.20170—
+4K171651Excelsius GPSGlobus Medical, Inc.2017691
+4K171369M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20178—
+4K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.201678—
+4K153370Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m, Incorporated201617—
+4K152211PCT SystemCentinel Spine, Inc.20150—
+4K143278LnK Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd.201513—
+4K150851Sure Lok Mini Posterior Cervical/Upper Thoracic SystemPrecision Spine, Inc.20153—
+4K142867Reliance Posterior Cervical-Thoracic SystemReliance Medical Systems, LLC20153—
+4K143249SOLSTICE OCT SystemLife Spine, Inc.20151—
+4K142558Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m20140—
+4K140734Nextgen Altius Oct SystemEbi, LLC20140—
+4K141284Caspian Spinal SystemK2m, Inc.20140—
+4K133288Caspian Oct Spinal SystemK2m, Inc.201418—
+4K133556Virage Oct Spinal Fixation SystemZimmer Spine, Inc.2014272
+4K140645Gibralt Rod-to-Rod Cross ConnectorsExactech Sarasota20141—
+4K133374Streamline Oct Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Rti Surgical, I20143—
+4K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014671
+4K130887S4C Navigation InstrumentsAesculap Implant System, Inc.201313—
+4K122877Range Spinal System, Small StatureK2m, Inc.201334—
+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—
+4K122378Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC)201271