510(k) Report

Devices descending from K050438

944 later devices reach Stealthstation System Update through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K253663Zeta Navigation SystemZeta Surgical, Inc.20260—
+1K182662NAV PAK Needle, NIM NAV PAK NeedleBoston Endo Surgical Tech,20190—
+1K170011StealthStation S8 Spine Software v1.0.0Medtronic Navigation2017126—
+1K162309StealthStation S8 System Platforms and StealthStation Cranial SoftwareMedtronic Navigation, Inc.201739Class I
+1K162830SIS SoftwareSurgical Information Sciences, Inc.20179—
+1K153555EM ENT Navigated SuctionsMedtronic Navigation, Inc.201618
+1K150216Synergy CranialMedtronic Navigation, Inc.2015149Class I
+1K141833Stylet, 23CM, Skull-Mount Patient Tracker, Non-Invasive Patient Tracker, Tracer Pointer…Medtronic Navigation, Inc.201532
+1K142344DISPOSABLE PASSIVE ACCESSORY FOR MEDTRONIC StealthStation SystemIzi Medical Products, LLC20151—
+1K140927Universal Navigation InstrumentsMedos International SARL20141—
+1K133444Stealthstation S7 / I7 / Fusion Navigation Systems, Axiem Navigation SystemMedtronic Navigation, Inc.20141721
+1K123307Nuvasive NVM5 SystemNuvasive, Inc.201333—
+1K124004Navigated CD Horizon Solera Screwdrivers, Taps, Iliac Taps, Legacy TapsMedtronic Navigation, Inc.20134041
+1K122211Synthes Navigable Pedicle Preparation InstrumentsSynthes Spine201220—
+1K120812RenaissanceMazor Robotics, Ltd.2012211
+1K112718Nuvasive NVM5 SystemNuvasive, Inc.201235—
+1K111811Bendini (TM) Spinal Rod Bending SystemNuvasive, Inc.201136—
+1K113228Renaissance SystemMazor Robotics, Ltd.201123—
+1K073467Spineassist SystemMazor Surgical Technologies, Ltd.200832—
+1K063607Spineassist SystemMazor Surgical Technologies, Ltd.200733—
+1K062640Stryker Navigation System - Cranial Module, Model 6000-650-000Stryker Instruments20065019
+1K060556Brigit Surgical DeviceZimmer, Inc.2006128—
+1K053610AbarisTraxtal Technologies, Inc.20062783
+2K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+2K253381Stealth AXiS™ Surgical System with Stealth AXiS™ Spine clinical applicationMedtronic Navigation, Inc.20260—
+2K242806Medyssey Navigation SystemMedyssey Co, Ltd.20250—
+2K241333Geniant Cranial (Navigated Neurosurgical Positioning Robot)Koh Young Technology, Inc.20251—
+2K241130“POINT” Kinguide Agile Hybrid Navigation System (PSHF01-000)Point Robotics MedTech, Inc.20242—
+2K233595Genesys Spine Sacroiliac Joint Fusion System with NavigationGenesys Spine20241—
+2K232572Kalitec Navigated Instrument SystemKalitec Direct, LLC Doing Business AS Kalitec Medical20230—
+2K230150OptimMRIRebrain, Sas20231—
+2K230087“POINT” Kinguide Agile Hybrid Navigation SystemPoint Robotics MedTech, Inc.20233—
+2K212194Stryker Q Guidance System with Cranial Guidance Software, CranialMask Tracker and…Stryker Corporation202312
+2K223108TELIGEN System Navigation Ready Indications (TELIGEN Access Probe, TELIGEN Clear)Medos International SARL20234—
+2K220241“POINT” Kinguide Robotic-Assisted Surgical SystemPoint Robotics MedTech, Inc.20224—
+2K212756Discectomy Navigation Ready Instruments and Universal Navigation Adaptor SetMedos International SARL20225—
+2K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+2K212245Spine and Trauma Navigation System, Spine & Trauma 3D Navigation, Instrument Selection…Brainlab AG202215—
+2K211254ARAI Surgical Navigation SystemSurgalign Spine Technologies20221—
+2K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+2K210859NextAR™ Spine PlatformMedacta International S.A.20214—
+2K212023Virage Navigation SystemZimmer Biomet Spine, Inc.20211—
+2K210574NuVasive Pulse SystemNu Vasive, Incorporated202121
+2K201661Symphony Navigation Ready Instruments and Universal Navigation Adaptor SetMedos International SARL20207—
+2K200845Navigation Module of the Momentum SystemUlrich Medical USA20200—
+2K201362CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System, Kyphon™ HV-R™ Bone CementMedtronic202038—
+2K201251CarboClear Navigated InstrumentsCarboFix Orthopedics, Ltd.20209—
+2K192663Joimax Intracs SystemJoimax GmbH20201—
+2K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+2K201175StealthStation Cranial Software v1.3.0Medtronic Navigation, Inc.20208—
+2K201189Stealthstation S8 Spine Software v1.3.0Medtronic Navigation, Inc.2020151
+2K192495Black Diamond Navigation InstrumentsOsseus Fusion Systems20200—
+2K190929xvision Spine system (XVS)Augmedics, Ltd.201931—
+2K192133Zimmer Biomet Universal Navigation SystemZimmer Biomet Spine, Inc.20190—
+2K190556Zimmer Biomet Universal Navigation SystemZimmer Biomet Spine, Inc.20190—
+2K191943SYMPHONY Navigation Ready Instruments, Universal Navigation Adaptor SetMedos International SARL20198—
+2K180523INTAI Surgery Navigation SystemIntai Technology Corporation20197—
+2K190672StealthStation Synergy Cranial S7 Software v.2.2.8, StealthStation Cranial Software v3.1.1Medtronic Navigation, Inc.20193Class I
+2K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+2K183019SIS Software version 3.3.0Surgical Information Sciences, Inc.20196—
+2K182077Mazor X System (Mazor X Stealth Edition)Mazor Robotics, Ltd.2018162
+2K181596Spine Wave Navigated InstrumentsSpine Wave, Inc.20181—
+2K1810417D Surgical System Cranial Application7D Surgical, Inc.20186—
+2K180948TruDi NAV Suction InstrumentsAcclarent, Inc.201805
+2K180038NuVasive Pulse SystemNu Vasive, Incorporated20183—
+2K172517SeaSpine Navigation SystemSeaSpine Orthopedics Corporation2018601
+2K1803527D Surgical System7D Surgical, Inc.20188—
+2K170937VIPER PRIME navigated inserterMedos International SARL20176—
+2K163209Fiagon Navigation SystemFiagon GmbH20170—
+2K171651Excelsius GPSGlobus Medical, Inc.2017691
+2K171267NavLock TrackersMedtronic Navigation201741
+2K170679CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC®…Medtronic Sofamor Danek201786—
+2K162199Cascade IOMAX Intraoperative MonitorCadwell Industries, Inc.201773
+2K162375Envision 3D: Image Guidance System7D Surgical, Inc.201621—
+2K153660StealthStation System with Cranial SoftwareMedtronic Navigation, Inc.2016144Class I
+2K161210RIALTO (TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC (TM)…Medtronic Sofamor Danek201679—
+2K160523BrightMatter Guide with BrightMatter PointerSynaptive Medical, Inc.20160—
+2K151156Fiagon Navigation SystemFiagon GmbH20161—
+2K153442CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with…Medtronic Sofamor Danek USA, Inc.201684—
+2K151511ROSA SpineMedtech S.A20161093
+2K151414IQQA GuideEdda Technology20151—
+2K152041Renaissance X SystemMazor Robotics, Ltd.201520—
+2K142024Brightmatter Navigation SystemSynaptive Medical, Inc.2015121
+2K140167Renaissance X SystemMazor Robotics, Ltd.201421—
+2K141551Profess Software, Profess Curved 70 (Degrees) Suction, Profess Curved 70 (Degrees)…Stryker Corporate2014201
+2K140400ES2 Neuromonitoring Accessory InstrumentsStryker Corporation20149—
+2K133901Pari-Path Surgical Navigation SystemParitic, Inc.20140—
+2K140454Navigated CD Horizon Solera Screwdriver/TapsMedtronic Sofamor Danek USA, Inc.20143961
+2K132694Nuvasive NVM5 SystemNu Vasive, Incorporated201424—
+2K131214Cranial Map NeuroStryker Corporate201326—
+2K131425Navigated Capstone Trials, Clydesdale Trials, Capstone & Clydesdale InserterMedtronic Navigation, Inc.201324610
+2K121498PercunavPhilips Health Care2012222—
+2K122742Nuvasive Bendini Spinal Rod Bending SystemNuvasive, Inc.201235—
+2K112717Nuvasive Nvjjb SystemNuvasive, Inc.20120—
+2K120187Multi-Modality Image FusionIgt, LLC Dba Eigen20124—
+2K102130Tenzing SystemMazor Surgical Technologies, Ltd.201031—
+2K093206Orthomap 3D 1.1 ModuleStryker Corp.20100—
+2K093672Aegis Navigation Anda Egis Pelvic ApplicationSentinelle Medical, Inc.20098—
+2K092239Rosa Surgical Device, Model Rosa 1.1Medtech S.A20091279
+2K092619Etrax Needle System, Etrax Variable Angle Needle Guidance System, Virtutrax Universal…Civco20096117