510(k) Report

Devices descending from K070106

119 later devices reach VV Fluoro 3D through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192703Cranial Image Guided Surgery System, Navigation Software Cranial, Navigation Software…Brainlab AG20203—
+1K191285Spine & Trauma NavigationBrainlab AG20190—
+1K172115Navigated Instrument SystemOrthofix, Inc.20184—
+1K162921Navigated Instrument SystemOrthofix, Inc.20175—
+1K140927Universal Navigation InstrumentsMedos International SARL20141—
+1K130887S4C Navigation InstrumentsAesculap Implant System, Inc.201313—
+1K122211Synthes Navigable Pedicle Preparation InstrumentsSynthes Spine201220—
+1K120867Viper and Expedium Navigated InstrumentsMedos International SARL20122—
+1K083310Spine & Trauma IctBrainlab AG200940—
+1K081386Model 6150 (MYLAB70) and Model 6100 (MYLAB90)Esaote, S.p.A.2008532
+2K223864Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial…Brainlab AG20231—
+2K223288Cranial Navigation, Navigation Software Cranial, Navigation Software Craniofacial…Brainlab AG20230—
+2K223108TELIGEN System Navigation Ready Indications (TELIGEN Access Probe, TELIGEN Clear)Medos International SARL20234—
+2K213491Universal Pilot Guidance Instrument SystemCtl Medical Corporation20220—
+2K212756Discectomy Navigation Ready Instruments and Universal Navigation Adaptor SetMedos International SARL20225—
+2K201661Symphony Navigation Ready Instruments and Universal Navigation Adaptor SetMedos International SARL20207—
+2K192495Black Diamond Navigation InstrumentsOsseus Fusion Systems20200—
+2K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+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—
+2K183605Spine & Trauma NavigationBrainlab AG2019253
+2K181890Brainlab Compatible K2M Navigation InstrumentsK2m201811—
+2K170937VIPER PRIME navigated inserterMedos International SARL20176—
+2K153700Aesculap (R) Implant Systems (AIS) S4 Navigation InstrumentsAesculap Implant Systems, LLC20160—
+2K142008Mylabseven, MylabalphaEsaote, S.p.A.2014193
+2K1339056200 / 6250 Ultrasound SystemEsaote, S.p.A.201434—
+2K1031526250 Ultrasound SytemsEsaote, S.p.A.201135—
+2K100931Mylabtwice, Model 6200Esaote, S.p.A.201046—
+2K091009MY LABS25 Gold/MYLAB30 Gold Cardiovascular Model 7340, MY LAB70/MY LAB70XVISION/MYLAB60…Esaote, S.p.A.200951—
+3K260240SYMPHONY Navigation Ready InstrumentsMedos International SARL20260—
+3K243698Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignment…Brainlab AG20250—
+3K242271Caduceus STaiwan Main Orthopaedic Biotechnology Co., Ltd.20240—
+3K241893CROSSNAV Navigation Enabled Instruments and UNAS Navigation ArraysMedos International SARL20241—
+3K233254TELIGEN System Navigation Ready InstrumentsDePuy Synthes20242—
+3K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+3K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+3K223438TELIGEN System Peripheral Motor Nerve Stimulation IndicationsMedos International SARL20230—
+3K220554Caduceus STaiwan Main Orthopaedic Biotechnology Co., Ltd.20220—
+3K212245Spine and Trauma Navigation System, Spine & Trauma 3D Navigation, Instrument Selection…Brainlab AG202215—
+3K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+3K203679Automatic RegistrationBrainlab AG20211—
+3K202320CIRQ Robotic Alignment Module, Cirq, Cirq Robotic Alignment Module Spinal, Cirq Robotic…Brainlab AG20209—
+3K201006K2M Navigation InstrumentsK2m, Inc.20200—
+3K192911Brainlab Compatible K2M Navigation InstrumentsK2m, Inc.20199—
+3K161999AixplorerSupersonic Imagine201620—
+3K161168MyLabSix Ultrasound SystemEsaote Europe B.V.20161—
+3K1613596400 Ultrasound System,7400 Ultrasound System, 7410 Ultrasound SystemEsaote, S.p.A.201645
+3K1532776200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A.201612—
+3K140677MylabssognoEsaote, S.p.A.20140—
+3K132466Mylabseven 6400, Mylabalpha 7400Esaote, S.p.A.201322—
+3K132231Mylabseven, MylabalphaEsaote, S.p.A.201322—
+3K121384MylabsognoEsaote, S.p.A.201211
+3K111302Mylabseven, MylabalphaEsaote, S.p.A.201124—
+3K110688MylabgoldEsaote2011251
+4K254157CROSSNAV Navigation Enabled Instruments for Disc Preparation and InterbodyMedos International SARL20260—
+4K254158SPINEART Navigation Instrument SystemSpineart SA20261—
+4K252755POINT Kinguide Agile Robotic Arm Surgical Stereotactic SystemPoint Robotics MedTech, Inc.20260—
+4K242933SPINEART Navigation Instrument SystemSpineart SA20252—
+4K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+4K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+4K234047Automatic RegistrationBrainlab AG20240—
+4K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+4K223553Spine Planning (2.0), Elements Spine Planning, Elements Planning SpineBrainlab AG20231—
+4K222966Cirq Arm System (2.0);Alignment System SpineBrainlab AG202201
+4K221618Spine & Trauma Navigation, Spine Navigation, Navigation Software Spine & Trauma…Brainlab AG20226—
+4K203205Navigated Spine InstrumentsStryker Spine20218—
+4K1910727410 Ultrasound System (MyLabSigma)Esaote, S.p.A.20190—
+4K1909896400 Ultrasound System (MyLabX6, MyLabX7)Esaote, S.p.A.20190—
+4K1904477400 Ultrasound SystemsNavigant Consulting - on Behalf of Esaote S.P.A.20190—
+4K1831916420 Ultrasound SystemEsaote, S.p.A.20180—
+4K171105AIXPLORER® & AIXPLORER® Ultimate Ultrasound SystemsSupersonic Imagine201719—
+4K163119NaviSuite SSI EditionMedcom GmbH20171—
+4K1630826200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A.201792
+4K162290MyLabSix CrystaLineEsaote, S.p.A.20160—
+4K142077MylabgammaEsaote, S.p.A.201453
+4K141486Mylabsix Ultrasound SystemEsaote Europe B.V.20148—
+5K262257Spine Planning (3.0); Spine & Trauma Navigation; Alignment System SpineBrainlab SE20260—
+5K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+5K252562Spine & Trauma Navigation InstrumentsBrainlab AG20250—
+5K242569Mixed Reality Spine NavigationBrainlab AG20250—
+5K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+5K240662Spine Guidance Software (version 5.0); Xia 3/ Serrato Q Instruments; Everest Q…Stryker Leibinger GmbH & Co KG20247—
+5K240701Drill Guide; Drill Bit; Spine & Trauma NavigationBrainlab AG20240—
+5K1732916440 Ultrasound SystemEsaote, S.p.A.20188—
+5K173021Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic SystemsSupersonic Imagine201818—
+5K170841BiopSee, Mobile USMedcom GmbH20170—
+6K260546Q Pedicle InstrumentsK2m, Inc.20260—
+6K252873Q Interbody InstrumentsK2m, Inc.20260—
+6K252871Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite Cutting…Stryker Leibinger GmbH & Co KG20261—
+6K241171Spine Guidance Software (Version 5.1); Consolidated Operating Room Equipment (CORE) 2…Stryker Leibinger GmbH & Co KG20244—
+6K2301796440 MyLabX90Esaote, S.p.A.202341
+6K200655FibroScan® 630Echosens20200—
+6K1921576450 Ultrasound systemEsaote, S.p.A.20194—
+6K180572AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20…Supersonic Imagine201816—
+7K253623Spine Guidance 5.4 Software; Spine Guidance 5.4 Upgrade; Spine Guidance 5.4 Update…Stryker Leibinger GmbH & Co KG20260—
+7K2432536600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70)Esaote, S.p.A.20252—
+7K2416716450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)Esaote, S.p.A.20252—
+7K243958Consolidated Operating Room Equipment (CORE) 2 ConsoleStryker Instruments20250—
+7K241517Q Guidance System; Mako Spine System;Stryker Leibinger GmbH & Co KG20242—