510(k) Report

Devices descending from K953076

357 later devices reach Townley Facet/Pedicular Screw Plating System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemEminent Spine20240—
+4K232468SC Medica FFXSc Medica20243—
+4K240085zLOCK Lumbar Facet Fixation SystemZygofix, Ltd.20242—
+4K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+4K240086Ion 3DSurGenTec, LLC20243—
+4K233332Statera-C™ Spinal SystemK&J Consulting Corp.20230—
+4K233366SYMPHONY OCT SystemMedos International SARL20230—
+4K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue®…Lesspine Innovations20230—
+4K231811Zavation Connector SystemZavation Medical Products, LLC20230—
+4K221307Edge Upper Cervical SystemSpinal Simplicity, LLC20230—
+4K230614Cortium™Ulrich Medical USA20230—
+4K223764INFINITY OCT SystemMedtronic Sofamor Danek USA, Inc.20230—
+4K220658COSY Cervicothoracic Occipital Rod-Screw SystemSignus Medizintechnik GmbH20220—
+4K222107Black Diamond™ POCT Spinal SystemOsseus Fusion Systems20220—
+4K213871Ennovate Cervical Spinal and Occiput SystemAesculap Implant Systems, LLC20220—
+4K220570M.U.S.T. MINI Posterior Cervical Screws System ExtensionMedacta International S.A.20220—
+4K220810Infinity™ OCT System and PASS OCT Spinal SystemMedicrea International20220—
+4K220025ARx® Spinal SystemLife Spine, Inc.20220—
+4K213654NuVasive Reline Cervical SystemNu Vasive, Incorporated20221—
+4K211805IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec…Alphatec Spine, Inc.202138—
+4K211957QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.20213—
+4K211993Z-LINKPC SystemZavation Medical Products, LLC20210—
+4K210449Infinity™ OCT System, PASS OCT® Spinal SystemMedtronic20213—
+4K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+4K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+4K200896Solstice CCILife Spine, Inc.20200—
+4K192013VERTICALE® Cervical SystemSilony Medical GmbH20202—
+4K193129Yukon OCT Spinal SystemK2m, Inc.202001
+4K192014SYPMHONY™ OCT SystemMedos International SARL20203—
+4K192281AEGIS Anterior Lumbar Plate System, ALC Dynamized Fixation System, Anterior ISOLA Spine…Medos International SARL20190—
+4K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+4K183589PMT Facet ScrewProvidence Medical Technology, Inc.20198—
+4K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+4K192354Innovasis Gibralt Spine SystemInnovasis, Inc.20190—
+4K191553NuVaisve® Reline® Cervical SystemNu Vasive, Incorporated20192—
+4K190895MOUNTAINEER OCT Spinal System, SUMMIT SI OCT Spinal Fixation System, SYMPHONY OCT…Medos International SARL20199—
+4K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc.201999—
+4K190071Perla® Posterior Cervico-Thoracic Fixation SystemSpineart20191—
+4K183383ANAX™ OCT Spinal SystemU&I Corporation20181—
+4K182954Salvo™ Spine SystemSpine Wave, Inc.20186—
+4K182182YUKON OCT Spinal SystemK2m20185—
+4K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+4K181440Proficient® Posterior Cervical Spine SystemSpine Wave, Inc.20184—
+4K180690Navigation InstrumentsGlobus Medical, Inc.20189—
+4K180851VERTEX™ Reconstruction SystemMedtronic Sofamor Danek USA, Inc.20188—
+4K173047The Solstice OCT SystemLife Spine, Inc.20180—
+4K180025Centurion POCT SystemOrthofix, Inc.20186—
+4K173522Solanas® Posterior Stabilization SystemAlphatec Spine, Inc.20175—
+4K172279PMT Posterior Fixation SystemProvidence Medical Technology, Inc.20170—
+4K171651Excelsius GPSGlobus Medical, Inc.2017691
+4K170647Connector SystemOrthofix, Inc.201718—
+4K162266The Cranial Fusion SystemLife Spine, Inc.20171—
+4K162300Reform® POCT SystemPrecision Spine, Inc.20162—
+4K160428Certex Spinal Fixation SystemX-Spine Systems, Inc.20160—
+4K153370Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m, Incorporated201617—
+4K153631Zimmer Virage OCT Spinal Fixation SystemZimmer Spine, Inc.201618—
+4K153169PASS OCT Patient Specific RodsMedicrea International20164—
+4K153336VuePoint OCT SystemNu Vasive, Incorporated20162—
+4K151755OASYS (r) SystemStryker Corporation201533—
+4K150223Facet-Link Stabilization PlatformFacet-Link, Inc.20150—
+5K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+5K252432Flex-Z™ Cervical CageSpinepoint, LLC20260—
+5K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+5K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+5K260038E3D™-C Interbody SystemEvolution Spine20261—
+5K250679FFX Facet Fixation SystemSc Medica20250—
+5K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+5K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+5K241525ExcelsiusXR™Globus Medical, Inc.20250—
+5K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+5K242527The Karma® Fixation SystemSpinal Elements, Inc.20250—
+5K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+5K250332Virage® OCT Spinal Fixation SystemHighridge Medical, LLC20250—
+5K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+5K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+5K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+5K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+5K240160EGPS Navigated InstrumentsAstura Medical20240—
+5K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+5K242650zLOCK Lumbar Facet Fixation SystemZygofix, Ltd.20240—
+5K241416Ion 3DSurGenTec, LLC20242—
+5K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+5K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+5K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+5K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+5K230639Align Cervical Interbody Fusion SystemAcuity Surgical Devices, LLC20232—
+5K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+5K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+5K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+5K223558CUVIS-spineCurexo, Inc.20230—
+5K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+5K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+5K220951PMT Facet Fixation System (PMT FFS)Providence Medical Technology, Inc.20227—
+5K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+5K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+5K220132FIREFLY® Cervical Navigation GuideMighty Oak Medical, Inc.20221—
+5K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+5K221388NuVasive Reline Cervical SystemNu Vasive, Incorporated20220—
+5K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+5K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—