510(k) Report

Devices descending from K061938

152 later devices reach Verte-Stack Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K062427Verte-Stack Spinal SystemMedtronic Sofamor Danek2006151—
+2K070742Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek2007150—
+3K180851VERTEX™ Reconstruction SystemMedtronic Sofamor Danek USA, Inc.20188—
+3K163375INFINITY™ OCT SystemMedtronic Sofamor Danek USA, Inc.2017165
+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—
+3K073420Blackstone Ascent Multiaxial ScrewsBlackstone Medical, Inc.20089—
+4K253195TAURUS Posterior Occipital-Cervico-Thoracic Spinal SystemsZheJiang Decans Medical Devices Co., Ltd.20260—
+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—
+4K223764INFINITY OCT SystemMedtronic Sofamor Danek USA, Inc.20230—
+4K220810Infinity™ OCT System and PASS OCT Spinal SystemMedicrea International20220—
+4K210449Infinity™ OCT System, PASS OCT® Spinal SystemMedtronic20213—
+4K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+4K192646SYMPHONY™ OCT SystemMedos International SARL20202—
+4K181350ASTRA-OCT Spine SystemSpinecraft, LLC20180—
+4K161032neon3™ universal OCT spinal stabilizationUlrich GmbH & Co. KG201671
+4K140734Nextgen Altius Oct SystemEbi, LLC20140—
+4K133556Virage Oct Spinal Fixation SystemZimmer Spine, Inc.2014272
+4K121877Gibralt Occipital Plate Screws, Set Screw, Gibralt Occipital System Articulating Rod…Exactech, Inc.20134—
+4K122378Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC)201271
+4K113593Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC)2012102—
+4K113346Neon SystemUlrich GmbH & Co. KG20121—
+4K111076Solanas Avalon Posterior Fixation SystemAlphatec Spine, Inc.20115—
+5K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+5K233078Posterior Cervical Spine SystemDouble Medical Technology, Inc.20231—
+5K233366SYMPHONY OCT SystemMedos International SARL20230—
+5K221307Edge Upper Cervical SystemSpinal Simplicity, LLC20230—
+5K230614Cortium™Ulrich Medical USA20230—
+5K203319SYMPHONY™ OCT SystemMedos International SARL20211—
+5K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+5K200571PERLA® Posterior Occipito-Cervico-Thoracic Fixation SystemSpineart20200—
+5K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+5K182837M.U.S.T. Mini ExtensionMedacta International S.A.20191—
+5K182182YUKON OCT Spinal SystemK2m20185—
+5K171444YUKON OCT Spinal SystemK2m, Inc.2017133
+5K162266The Cranial Fusion SystemLife Spine, Inc.20171—
+5K162575Z-LINKPC SystemZavation, LLC20173—
+5K150918PASS OCT Spinal SystemMedicrea International SA201513—
+5K150254Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)201523
+5K141284Caspian Spinal SystemK2m, Inc.20140—
+5K133374Streamline Oct Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Rti Surgical, I20143—
+5K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014671
+5K131833Centurion Poct SystemOrthofix, Inc.20142—
+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—
+6K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+6K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+6K250866Sovereign Posterior Cervical SystemMet One Technologies, LLC20251—
+6K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+6K231811Zavation Connector SystemZavation Medical Products, LLC20230—
+6K222107Black Diamond™ POCT Spinal SystemOsseus Fusion Systems20220—
+6K203149M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20200—
+6K200896Solstice CCILife Spine, Inc.20200—
+6K193129Yukon OCT Spinal SystemK2m, Inc.202001
+6K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+6K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+6K173522Solanas® Posterior Stabilization SystemAlphatec Spine, Inc.20175—
+6K171369M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20178—
+6K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+6K161498Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20161—
+6K161149PASS OCT Spinal SystemMedicrea International SA20160—
+6K160756PASS OCT Spinal SystemMedicrea International SA20160—
+6K153169PASS OCT Patient Specific RodsMedicrea International20164—
+6K152211PCT SystemCentinel Spine, Inc.20150—
+6K151974Polaris Spinal SystemBiomet Spine201516—
+6K150896Vitality Spinal Fixation SystemZimmer Spine, Inc.2015193
+6K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+6K150229SOLSTICE OCT SystemLife Spine, Inc.20150—
+6K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+6K140123Polaris Spinal System -Translation ScrewEbi, LLC2014221
+6K132504Tiger Occipital-Cervical-Thoracic Spinal Fixation SystemCorelink, LLC20132—
+6K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)201370—
+7K254260The VEGA Cervical Screw SystemGS Medical Co., Ltd.20260—
+7K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+7K230325GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal SystemGreens Surgicals Pvt., Ltd.20240—
+7K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+7K220570M.U.S.T. MINI Posterior Cervical Screws System ExtensionMedacta International S.A.20220—
+7K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+7K210275Polaris Spinal SystemZimmer Biomet Spine, Inc.20210—
+7K200303Reform Pedicle Screw SystemPrecision Spine202010—
+7K200863Tiger® Occipital-Cervical-Thoracic Spinal Fixation SystemCorelink, LLC20200—
+7K200130M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20206—
+7K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+7K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+7K191185Solanas® Posterior OCT Fixation SystemAlphatec Spine20194—
+7K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+7K183080Mega Plus Spine SystemBk Meditech, Co., Ltd.20182—
+7K180433Ennovate®Aesculap Implant Systems, LLC201811
+7K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179—
+7K172139Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20170—
+7K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.20170—
+7K171907Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc.2017162
+7K150856Reform Pedicle Screw SystemPrecision Spine, Inc.201526—
+7K141804Polaris Spinal System - HA CoatedBiomet Spine, LLC201421—
+8K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—