510(k) Report

Devices descending from K981508

145 later devices reach Vectorvision Spine Module through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K024192Vectorvision FLUORO3DBrainlab AG2003144—
+2K070106VV Fluoro 3DBrainlab AG2007119Class I
+2K062086NavivisionBrainlab AG200677—
+3K192703Cranial Image Guided Surgery System, Navigation Software Cranial, Navigation Software…Brainlab AG20203—
+3K191285Spine & Trauma NavigationBrainlab AG20190—
+3K172115Navigated Instrument SystemOrthofix, Inc.20184—
+3K162921Navigated Instrument SystemOrthofix, Inc.20175—
+3K140927Universal Navigation InstrumentsMedos International SARL20141—
+3K130887S4C Navigation InstrumentsAesculap Implant System, Inc.201313—
+3K122211Synthes Navigable Pedicle Preparation InstrumentsSynthes Spine201220—
+3K120867Viper and Expedium Navigated InstrumentsMedos International SARL20122—
+3K081509Monteris Medical Autolitt Laser ProbeMonteris Medical,200922—
+3K083310Spine & Trauma IctBrainlab AG200940—
+3K081386Model 6150 (MYLAB70) and Model 6100 (MYLAB90)Esaote, S.p.A.2008532
+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—
+4K192495Black Diamond Navigation InstrumentsOsseus Fusion Systems20200—
+4K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+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
+4K181890Brainlab Compatible K2M Navigation InstrumentsK2m201811—
+4K182036NeuroBlate SystemMonteris Medical,201811—
+4K172881NeuroBlate SystemMonteris Medical,201713—
+4K170937VIPER PRIME navigated inserterMedos International SARL20176—
+4K153700Aesculap (R) Implant Systems (AIS) S4 Navigation InstrumentsAesculap Implant Systems, LLC20160—
+4K142008Mylabseven, MylabalphaEsaote, S.p.A.2014193
+4K1339056200 / 6250 Ultrasound SystemEsaote, S.p.A.201434—
+4K120561Neuroblate SystemMonteris Medical, Inc.2013211
+4K1031526250 Ultrasound SytemsEsaote, S.p.A.201135—
+4K100931Mylabtwice, Model 6200Esaote, S.p.A.201046—
+4K091009MY LABS25 Gold/MYLAB30 Gold Cardiovascular Model 7340, MY LAB70/MY LAB70XVISION/MYLAB60…Esaote, S.p.A.200951—
+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—
+5K241893CROSSNAV Navigation Enabled Instruments and UNAS Navigation ArraysMedos International SARL20241—
+5K233254TELIGEN System Navigation Ready InstrumentsDePuy Synthes20242—
+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—
+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—
+5K203679Automatic RegistrationBrainlab AG20211—
+5K202320CIRQ Robotic Alignment Module, Cirq, Cirq Robotic Alignment Module Spinal, Cirq Robotic…Brainlab AG20209—
+5K201056NeuroBlate SystemMonteris Medical, Inc.20209—
+5K201006K2M Navigation InstrumentsK2m, Inc.20200—
+5K193375NeuroBlate SystemMonteris Medical,202010—
+5K192911Brainlab Compatible K2M Navigation InstrumentsK2m, Inc.20199—
+5K173305NeuroBlate SystemMonteris Medical,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
+5K131278Monteris Medical Neuroblate SystemMonteris Medical, Inc.2013191
+5K121384MylabsognoEsaote, S.p.A.201211
+5K111302Mylabseven, MylabalphaEsaote, S.p.A.201124—
+5K110688MylabgoldEsaote2011251
+6K254157CROSSNAV Navigation Enabled Instruments for Disc Preparation and InterbodyMedos International SARL20260—
+6K254158SPINEART Navigation Instrument SystemSpineart SA20261—
+6K252755POINT Kinguide Agile Robotic Arm Surgical Stereotactic SystemPoint Robotics MedTech, Inc.20260—
+6K242933SPINEART Navigation Instrument SystemSpineart SA20252—
+6K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+6K240877Monteris Medical NeuroBlate SystemMonteris Medical,20245—
+6K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+6K234047Automatic RegistrationBrainlab AG20240—
+6K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+6K223553Spine Planning (2.0), Elements Spine Planning, Elements Planning SpineBrainlab AG20231—
+6K222983NeuroBlate Fusion-S Software V3.17Monteris Medical,20237—
+6K222966Cirq Arm System (2.0);Alignment System SpineBrainlab AG202201
+6K221618Spine & Trauma Navigation, Spine Navigation, Navigation Software Spine & Trauma…Brainlab AG20226—
+6K211269Visualase MRI-Guided Laser Ablation System (SW 3.4)Medtronic Navigation, Inc.202271
+6K203205Navigated Spine InstrumentsStryker Spine20218—
+6K1910727410 Ultrasound System (MyLabSigma)Esaote, S.p.A.20190—
+6K1909896400 Ultrasound System (MyLabX6, MyLabX7)Esaote, S.p.A.20190—
+6K1904477400 Ultrasound SystemsNavigant Consulting - on Behalf of Esaote S.P.A.20190—
+6K1831916420 Ultrasound SystemEsaote, S.p.A.20180—
+6K171255Monteris Medical NeuroBlate SystemMonteris Medical, Inc.201714Class I
+6K171105AIXPLORER® & AIXPLORER® Ultimate Ultrasound SystemsSupersonic Imagine201719—
+6K163119NaviSuite SSI EditionMedcom GmbH20171—
+6K1630826200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A.201792
+6K162290MyLabSix CrystaLineEsaote, S.p.A.20160—
+6K143457NeuroBlate SystemMonteris Medical, Inc.201517Class I
+6K142077MylabgammaEsaote, S.p.A.201453
+6K141486Mylabsix Ultrasound SystemEsaote Europe B.V.20148—
+7K262257Spine Planning (3.0); Spine & Trauma Navigation; Alignment System SpineBrainlab SE20260—
+7K262315NeuroBlate SystemMonteris Medical20260—