510(k) Report

Devices descending from K022048

181 later devices reach Interpore Cross International (Ici) Occipito-Cervico-Thoracic (Oct) Rod and… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K113593Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC)2012102—
+1K072729SierraSeaspine, Inc.20085—
+1K080526Sierra SystemSeaspine, Inc.20089—
+1K062934SierraSeaspine, Inc.200621—
+1K052402Vertex Reconstruction SystemMedtronic Sofamor Danek2005180—
+2K231654NorthStar OCT SystemSeaspine, Inc.20230—
+2K193615NorthStar™ OCT Spinal SystemSeaSpine Orthopedics Corporation20201—
+2K180851VERTEX™ Reconstruction SystemMedtronic Sofamor Danek USA, Inc.20188—
+2K171444YUKON OCT Spinal SystemK2m, Inc.2017133
+2K140734Nextgen Altius Oct SystemEbi, LLC20140—
+2K133288Caspian Oct Spinal SystemK2m, Inc.201418—
+2K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014671
+2K133698Synapse SystemSynthes USA Products, LLC20146—
+2K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC)2013752
+2K121725Pioneer Posterior Occipito-Cervico-Thoracic (Oct) SystemPioneer Surgical Technology, Inc.201217—
+2K122163Certex Spinal Implant SystemX-Spine Systems, Inc.20122—
+2K120998Solstice Cross ConnectorLife Spine20121—
+2K122378Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC)201271
+2K120467Spinal Elements Posterior Cervical/Thoracic Spinal SystemSpinal Elements, Inc.20121—
+2K112025Sure Lok Mini Posterior Cervical/Upper Thoracic SystemSpinal USA20114—
+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—
+3K222107Black Diamond™ POCT Spinal SystemOsseus Fusion Systems20220—
+3K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+3K200571PERLA® Posterior Occipito-Cervico-Thoracic Fixation SystemSpineart20200—
+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—
+3K181350ASTRA-OCT Spine SystemSpinecraft, LLC20180—
+3K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+3K163375INFINITY™ OCT SystemMedtronic Sofamor Danek USA, Inc.2017165
+3K171369M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20178—
+3K162575Z-LINKPC SystemZavation, LLC20173—
+3K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+3K160428Certex Spinal Fixation SystemX-Spine Systems, Inc.20160—
+3K153370Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m, Incorporated201617—
+3K152211PCT SystemCentinel Spine, Inc.20150—
+3K151974Polaris Spinal SystemBiomet Spine201516—
+3K150896Vitality Spinal Fixation SystemZimmer Spine, Inc.2015193
+3K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+3K150851Sure Lok Mini Posterior Cervical/Upper Thoracic SystemPrecision Spine, Inc.20153—
+3K150229SOLSTICE OCT SystemLife Spine, Inc.20150—
+3K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+3K141897Synapse System, Synthes OC Fusion SystemSynthes USA Products, LLC20145—
+3K141284Caspian Spinal SystemK2m, Inc.20140—
+3K140123Polaris Spinal System -Translation ScrewEbi, LLC2014221
+3K133374Streamline Oct Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Rti Surgical, I20143—
+3K131833Centurion Poct SystemOrthofix, Inc.20142—
+3K133094Certex Oct Spinal Implant SystemX-Spine Systems, Inc.20131—
+3K132504Tiger Occipital-Cervical-Thoracic Spinal Fixation SystemCorelink, LLC20132—
+3K131427LOTUSSpinal Elements, Inc.20130—
+3K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)201370—
+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—
+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—
+4K250866Sovereign Posterior Cervical SystemMet One Technologies, LLC20251—
+4K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+4K230325GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal SystemGreens Surgicals Pvt., Ltd.20240—
+4K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+4K233366SYMPHONY OCT SystemMedos International SARL20230—
+4K231811Zavation Connector SystemZavation Medical Products, LLC20230—
+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—
+4K220570M.U.S.T. MINI Posterior Cervical Screws System ExtensionMedacta International S.A.20220—
+4K220810Infinity™ OCT System and PASS OCT Spinal SystemMedicrea International20220—
+4K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+4K210275Polaris Spinal SystemZimmer Biomet Spine, Inc.20210—
+4K210449Infinity™ OCT System, PASS OCT® Spinal SystemMedtronic20213—
+4K203319SYMPHONY™ OCT SystemMedos International SARL20211—
+4K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+4K203149M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20200—
+4K200303Reform Pedicle Screw SystemPrecision Spine202010—
+4K200863Tiger® Occipital-Cervical-Thoracic Spinal Fixation SystemCorelink, LLC20200—
+4K200130M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20206—
+4K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+4K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+4K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+4K182837M.U.S.T. Mini ExtensionMedacta International S.A.20191—
+4K183080Mega Plus Spine SystemBk Meditech, Co., Ltd.20182—
+4K180433Ennovate®Aesculap Implant Systems, LLC201811
+4K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179—
+4K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.20170—
+4K171907Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc.2017162
+4K161032neon3™ universal OCT spinal stabilizationUlrich GmbH & Co. KG201671
+4K162300Reform® POCT SystemPrecision Spine, Inc.20162—
+4K150918PASS OCT Spinal SystemMedicrea International SA201513—
+4K150856Reform Pedicle Screw SystemPrecision Spine, Inc.201526—
+4K142867Reliance Posterior Cervical-Thoracic SystemReliance Medical Systems, LLC20153—