510(k) Report

Devices descending from K010968

225 later devices reach Vectorvision CT/Fluoro through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K053159Vectorvision SpineBrainlab AG20061551
+1K042721Kolibri SpineBrainlab AG2005187—
+1K033413Spineassist DeviceMazor Surgical Technologies, Ltd.200435—
+1K024192Vectorvision FLUORO3DBrainlab AG2003144—
+2K130887S4C Navigation InstrumentsAesculap Implant System, Inc.201313—
+2K110204Brainlab TraumaBrainlab AG201127—
+2K073467Spineassist SystemMazor Surgical Technologies, Ltd.200832—
+2K063607Spineassist SystemMazor Surgical Technologies, Ltd.200733—
+2K070106VV Fluoro 3DBrainlab AG2007119Class I
+2K063408Ctlogics Navigations SystemsPraxim Medivision, SA200734—
+2K062086NavivisionBrainlab AG200677—
+2K051676Spineassist Device with Additional AccessoriesMazor Surgical Technologies, Ltd.200534—
+3K221618Spine & Trauma Navigation, Spine Navigation, Navigation Software Spine & Trauma…Brainlab AG20226—
+3K192703Cranial Image Guided Surgery System, Navigation Software Cranial, Navigation Software…Brainlab AG20203—
+3K191285Spine & Trauma NavigationBrainlab AG20190—
+3K181890Brainlab Compatible K2M Navigation InstrumentsK2m201811—
+3K172115Navigated Instrument SystemOrthofix, Inc.20184—
+3K162567ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho2017151
+3K162921Navigated Instrument SystemOrthofix, Inc.20175—
+3K153700Aesculap (R) Implant Systems (AIS) S4 Navigation InstrumentsAesculap Implant Systems, LLC20160—
+3K140927Universal Navigation InstrumentsMedos International SARL20141—
+3K122211Synthes Navigable Pedicle Preparation InstrumentsSynthes Spine201220—
+3K122011Navigation Software Hip-Universal; Navigation Software Hip THR-AesculapBrainlab AG201251
+3K120867Viper and Expedium Navigated InstrumentsMedos International SARL20122—
+3K102130Tenzing SystemMazor Surgical Technologies, Ltd.201031—
+3K081509Monteris Medical Autolitt Laser ProbeMonteris Medical,200922—
+3K083310Spine & Trauma IctBrainlab AG200940—
+3K081386Model 6150 (MYLAB70) and Model 6100 (MYLAB90)Esaote, S.p.A.2008532
+3K081232Total Knee Surgetics Navigation System with PraxitelesPraxim200818—
+4K262257Spine Planning (3.0); Spine & Trauma Navigation; Alignment System SpineBrainlab SE20260—
+4K252562Spine & Trauma Navigation InstrumentsBrainlab AG20250—
+4K242569Mixed Reality Spine NavigationBrainlab AG20250—
+4K241893CROSSNAV Navigation Enabled Instruments and UNAS Navigation ArraysMedos International SARL20241—
+4K240701Drill Guide; Drill Bit; Spine & Trauma NavigationBrainlab AG20240—
+4K223864Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial…Brainlab AG20231—
+4K223288Cranial Navigation, Navigation Software Cranial, Navigation Software Craniofacial…Brainlab AG20230—
+4K223108TELIGEN System Navigation Ready Indications (TELIGEN Access Probe, TELIGEN Clear)Medos International SARL20234—
+4K213491Universal Pilot Guidance Instrument SystemCtl Medical Corporation20220—
+4K212756Discectomy Navigation Ready Instruments and Universal Navigation Adaptor SetMedos International SARL20225—
+4K201661Symphony Navigation Ready Instruments and Universal Navigation Adaptor SetMedos International SARL20207—
+4K201006K2M Navigation InstrumentsK2m, Inc.20200—
+4K193307HIP7Brainlab AG20200—
+4K192495Black Diamond Navigation InstrumentsOsseus Fusion Systems20200—
+4K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+4K192911Brainlab Compatible K2M Navigation InstrumentsK2m, Inc.20199—
+4K192133Zimmer Biomet Universal Navigation SystemZimmer Biomet Spine, Inc.20190—
+4K190556Zimmer Biomet Universal Navigation SystemZimmer Biomet Spine, Inc.20190—
+4K191943SYMPHONY Navigation Ready Instruments, Universal Navigation Adaptor SetMedos International SARL20198—
+4K183605Spine & Trauma NavigationBrainlab AG2019253
+4K182036NeuroBlate SystemMonteris Medical,201811—
+4K181449Ortoma Treatment Solution - OTSOrtoma AB20183—
+4K173372ExactechGPS Total Shoulder ApplicationBlue Ortho2017141
+4K172881NeuroBlate SystemMonteris Medical,201713—
+4K170937VIPER PRIME navigated inserterMedos International SARL20176—
+4K142008Mylabseven, MylabalphaEsaote, S.p.A.2014193
+4K1339056200 / 6250 Ultrasound SystemEsaote, S.p.A.201434—
+4K120561Neuroblate SystemMonteris Medical, Inc.2013211
+4K110911Renaissance SystemMazor Robotics, Ltd.201124—
+4K103400Fluoromap Software, 9 Fluorodisc (Belt), 12 Fluoro Disc (Belt), Close Tube ClipStryker Corporation20115—
+4K1031526250 Ultrasound SytemsEsaote, S.p.A.201135—
+4K100931Mylabtwice, Model 6200Esaote, S.p.A.201046—
+4K090953Total Knee Surgetics Navigation System with IblockPraxim Medivision, SA2010172
+4K091009MY LABS25 Gold/MYLAB30 Gold Cardiovascular Model 7340, MY LAB70/MY LAB70XVISION/MYLAB60…Esaote, S.p.A.200951—
+5K254157CROSSNAV Navigation Enabled Instruments for Disc Preparation and InterbodyMedos International SARL20260—
+5K260240SYMPHONY Navigation Ready InstrumentsMedos International SARL20260—
+5K243698Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignment…Brainlab AG20250—
+5K242271Caduceus STaiwan Main Orthopaedic Biotechnology Co., Ltd.20240—
+5K233254TELIGEN System Navigation Ready InstrumentsDePuy Synthes20242—
+5K232140OTS HipOrtoma AB202421
+5K231061NeuroBlate SystemMonteris Medical,20236—
+5K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+5K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+5K223438TELIGEN System Peripheral Motor Nerve Stimulation IndicationsMedos International SARL20230—
+5K222510Blueprint Mixed Reality systemTornier S.A.S.2023010
+5K220554Caduceus STaiwan Main Orthopaedic Biotechnology Co., Ltd.20220—
+5K212245Spine and Trauma Navigation System, Spine & Trauma 3D Navigation, Instrument Selection…Brainlab AG202215—
+5K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+5K213546ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho202281
+5K210153NextAR RSA PlatformMedacta International S.A.202151
+5K203205Navigated Spine InstrumentsStryker Spine20218—
+5K203679Automatic RegistrationBrainlab AG20211—
+5K202769VELYS™ Robotic-Assisted SolutionDepuy Ireland UC202131
+5K202320CIRQ Robotic Alignment Module, Cirq, Cirq Robotic Alignment Module Spinal, Cirq Robotic…Brainlab AG20209—
+5K201056NeuroBlate SystemMonteris Medical, Inc.20209—
+5K193375NeuroBlate SystemMonteris Medical,202010—
+5K182359HipCheckStryker Corp.20181—
+5K173946ADAPT for Gamma3Stryker GmbH20182—
+5K173305NeuroBlate SystemMonteris Medical,201712—
+5K163338OMNIBotics Knee SystemOmnllife Science, Inc.201712—
+5K170724NeuroBlate SystemMonteris Medical,201715—
+5K161999AixplorerSupersonic Imagine201620—
+5K162762NeuroBlate SystemMonteris Medical, Inc.201616—
+5K161168MyLabSix Ultrasound SystemEsaote Europe B.V.20161—
+5K1613596400 Ultrasound System,7400 Ultrasound System, 7410 Ultrasound SystemEsaote, S.p.A.201645
+5K1532776200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A.201612—
+5K141983Neuroblate SystemMonteris Medical Corp.2014182
+5K140677MylabssognoEsaote, S.p.A.20140—
+5K132466Mylabseven 6400, Mylabalpha 7400Esaote, S.p.A.201322—
+5K132231Mylabseven, MylabalphaEsaote, S.p.A.201322—
+5K131955Neuroblate (TM) SystemMonteris Medical, Inc.2013192