510(k) Report

Devices descending from K062807

676 later devices reach TSRH Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K072429Modification to TSRH Spinal SystemMedtronic Sofamor Danek200710—
+1K072317Modification to:TSRH Spinal SystemMedtronic Sofamor Danek USA, Inc.20076254
+1K070742Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek2007150—
+2K180851VERTEX™ Reconstruction SystemMedtronic Sofamor Danek USA, Inc.20188—
+2K163375INFINITY™ OCT SystemMedtronic Sofamor Danek USA, Inc.2017165
+2K123656Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc.201339—
+2K110896Reliance Spinal Screw SystemReliance Medical Systems, LLC20125—
+2K110522Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc.2011106—
+2K101112Reliance Spinal Screw SystemReliance Medical Systems20107—
+2K093434Vertex Reconstruction System and Vertex Select Reconstruction SystemMedtronic Sofamor Danek20097—
+2K092676TSRH Spinal SystemMedtronic Sofamor Danek, Inc.20090—
+2K090740Modification to: TSRH Spinal SystemMedtronic Sofamor Danek20091—
+2K081978Reliance Spinal Screw SystemReliance Medical Systems, LLC20098—
+2K081080TSRH Spinal SystemMedtronic Sofamor Danek2008614—
+2K073420Blackstone Ascent Multiaxial ScrewsBlackstone Medical, Inc.20089—
+2K073430Valeo Pedicle Screw Spinal SystemAmedica Corp.200824—
+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—
+3K253129Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20250—
+3K251725ANAX™ OCT Spinal SystemCg Medtech Co., Ltd.20250—
+3K223764INFINITY OCT SystemMedtronic Sofamor Danek USA, Inc.20230—
+3K220810Infinity™ OCT System and PASS OCT Spinal SystemMedicrea International20220—
+3K213750VyLink™ Spinal Screw SystemVy Spine, LLC20221—
+3K210449Infinity™ OCT System, PASS OCT® Spinal SystemMedtronic20213—
+3K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+3K192646SYMPHONY™ OCT SystemMedos International SARL20202—
+3K181350ASTRA-OCT Spine SystemSpinecraft, LLC20180—
+3K161032neon3™ universal OCT spinal stabilizationUlrich GmbH & Co. KG201671
+3K162066Reliance Spinal Screw SystemReliance Medical Systems, LLC20163—
+3K162160Preference Elite Pedicle Screw SystemAmedica Corporation20161—
+3K151704Diplomat® Spinal SystemSignus Medizintechnik GmbH20164—
+3K152131Reliance Spinal Screw SystemReliance Medical Systems, LLC20154—
+3K143230Palladian Lumbar Pedicle Screw SystemNeurostructures, Inc.20150—
+3K140734Nextgen Altius Oct SystemEbi, LLC20140—
+3K141282PGS 5.5 MM Cannulated Pedicle ScrewPinnacle Spine Group20141—
+3K133556Virage Oct Spinal Fixation SystemZimmer Spine, Inc.2014272
+3K133287Presson Spinal Fixation SystemNexus Spine, LLC20141—
+3K121877Gibralt Occipital Plate Screws, Set Screw, Gibralt Occipital System Articulating Rod…Exactech, Inc.20134—
+3K123521Reliance Spinal Screw SystemReliance Medical Systems, LLC20135—
+3K122378Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC)201271
+3K113593Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC)2012102—
+3K113346Neon SystemUlrich GmbH & Co. KG20121—
+3K111076Solanas Avalon Posterior Fixation SystemAlphatec Spine, Inc.20115—
+3K091797TSRH Spinal SystemMedtronic Sofamor Danek2010606—
+3K080767Conquest Spinal SystemLife Spine200821—
+4K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+4K243281LOCK-IN Spinal Fixation SystemLock-In USA Corp20240—
+4K233078Posterior Cervical Spine SystemDouble Medical Technology, Inc.20231—
+4K233366SYMPHONY OCT SystemMedos International SARL20230—
+4K231744VyLink™ Spinal Screw SystemVy Spine, LLC20230—
+4K221307Edge Upper Cervical SystemSpinal Simplicity, LLC20230—
+4K230614Cortium™Ulrich Medical USA20230—
+4K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+4K212185Golden Isles Pedicle Screw SystemIntelivation, LLC20210—
+4K210874Reliance Spinal Screw SystemReliance Medical Systems, LLC20212—
+4K203319SYMPHONY™ OCT SystemMedos International SARL20211—
+4K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+4K200571PERLA® Posterior Occipito-Cervico-Thoracic Fixation SystemSpineart20200—
+4K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+4K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+4K182837M.U.S.T. Mini ExtensionMedacta International S.A.20191—
+4K182182YUKON OCT Spinal SystemK2m20185—
+4K171444YUKON OCT Spinal SystemK2m, Inc.2017133
+4K162266The Cranial Fusion SystemLife Spine, Inc.20171—
+4K162575Z-LINKPC SystemZavation, LLC20173—
+4K160820PressON Pro Spinal Fixation SystemNexus Spine, LLC20160—
+4K150918PASS OCT Spinal SystemMedicrea International SA201513—
+4K150254Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)201523
+4K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.201513—
+4K141284Caspian Spinal SystemK2m, Inc.20140—
+4K133153Spinefrontier Pedfuse Pedicle Screw SystemSpinefrontier, Inc.20141—
+4K133374Streamline Oct Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Rti Surgical, I20143—
+4K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014671
+4K131833Centurion Poct SystemOrthofix, Inc.20142—
+4K123373Nautilus Spinal SystemLife Spine201317—
+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—
+4K111953Nautilus Spinal SystemLife Spine20123—
+4K112555CD Horizon (R) Spinal SystemMedtronic Sofamor Danek USA, Inc.2011597—
+4K101790Quantum Spinal System, Quantum MisPioneer Surgical Technology201110—
+4K090320Conquest Spinal SystemLife Spine20092—
+5K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+5K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+5K250866Sovereign Posterior Cervical SystemMet One Technologies, LLC20251—
+5K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+5K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+5K231811Zavation Connector SystemZavation Medical Products, LLC20230—
+5K222107Black Diamond™ POCT Spinal SystemOsseus Fusion Systems20220—
+5K220025ARx® Spinal SystemLife Spine, Inc.20220—
+5K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+5K210549ARx Spinal SystemLife Spine, Inc.20211—
+5K203149M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20200—
+5K200896Solstice CCILife Spine, Inc.20200—
+5K193129Yukon OCT Spinal SystemK2m, Inc.202001
+5K192800Streamline TL Spinal Fixation SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20203—
+5K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+5K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+5K173522Solanas® Posterior Stabilization SystemAlphatec Spine, Inc.20175—