510(k) Report

Devices descending from K003589

882 later devices reach Vectorvision Cranial, Vectorvision Spinal, Vectorvision Ent through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K061479ARGOS3D Line Medical Systems S.R.L.20070—
+1K023651Vectorvision Cranial/EntBrainlab AG20041481
+1K020631IPLANBrainlab AG2002343—
+1K014256Kolibri Igs SystemsBrainlab AG2002419—
+1K013428Mayfield/Acciss Operating Arm System and Mayfield/Optical Acciss SystemOhio Medical Instrument Co., Inc.20021—
+1K012448Vectorvision TraumaBrainlab AG2002251—
+1K012564Modification to: Vectorvision Frameless Biopsy SystemBrainlab AG200155—
+2K140705Navigable Brain Biopsy Cannula SetIzi Medical Products20140—
+2K123307Nuvasive NVM5 SystemNuvasive, Inc.201333—
+2K122096Karl Storz Navigationpanel Unit (Npu) SystemKARL STORZ Endoscopy-America, Inc.20125—
+2K110021Dash HipBrainlab AG201147—
+2K102251Dash KneeBrainlab AG201110—
+2K101791Rosa Surgical DeviceMedtech S.A.S201012612
+2K083597Sonowand InviteSonowand AS20093—
+2K090420Smith & Nephew Pigalileo Screw Targeting System V 1.0Smith & Nephew, Inc.200978—
+2K082060Cranial Image Guided Surgery SystemBrainlab AG200916—
+2K081386Model 6150 (MYLAB70) and Model 6100 (MYLAB90)Esaote, S.p.A.2008532
+2K062358Modification to Vectorvision TraumaBrainlab AG200734—
+2K061224Lapdoc IRobodent GmbH20060—
+2K060727Vectorvision HipBrainlab AG200671—
+2K051734GE Healthcare Insta Trak 3500PLUS/ Fluoro Trak 9800 Plus System with Axcess Bone Pin…Ge Healthcare Technologies200501
+2K052213Navigation SW Hip 3.1 on CIBrainlab AG2005170—
+2K050651Medtronic Orthopaedic Trauma ApplicationMedtronic Navigation, Inc.20051—
+2K041897Mayfield Acciss II Image Guided Surgery System, Model 2002-01Schaerer Mayfield USA, Inc.20050—
+2K042543Iplan! Digital TemplatingBrainlab AG20057—
+2K042721Kolibri SpineBrainlab AG2005187—
+2K042512Vectorvision AclBrainlab AG200557—
+2K041703IPLAN!Brainlab AG200456—
+2K042391Kolibri Image Guided Surgery SystemBrainlab AG200472—
+2K041330Iplan! FlowBrainlab AG20042—
+2K040050Instatrak System with Multiple Dataset Navigation, Model IT3500Ge Medical Systems Navigation and Visualization IN2004280Class I
+2K032511Intuition ImageBrainlab AG200435—
+2K031770CI TKR/UkrBrainlab AG2003134—
+3K213989Cranial EM SystemBrainlab AG20221—
+3K220652Knee 3Brainlab AG20220—
+3K203251SOLOPASS SystemIntravent Medical Partners, LP20211—
+3K201752Disposable Pre-calibrated SuctionBrainlab AG20210—
+3K190250Microscope NavigationBrainlab AG20190—
+3K172820Microscope Navigation SoftwareBrainlab AG20181—
+3K172462OrthAlign Plus SystemOrthalign, Inc.20178—
+3K172522Mazor XMazor Robotics, Ltd.20170—
+3K163439NaviENTClaronav, Inc.20171—
+3K161555KARL STORZ NAV1 Electromagnetic Navigation SystemKarl Storz Endoscopy America, Inc.20162—
+3K151511ROSA SpineMedtech S.A20161093
+3K151359ROSA BrainMedtech S.A201520Class I
+3K143420SYMBIS Surgical SystemImris, Inc.20150—
+3K142008Mylabseven, MylabalphaEsaote, S.p.A.2014193
+3K133759Intellijoint HipIntellijoint Surgical, Inc.201410—
+3K140400ES2 Neuromonitoring Accessory InstrumentsStryker Corporation20149—
+3K140331Orthalign Plus SystemOrthalign, Inc.201429—
+3K132694Nuvasive NVM5 SystemNu Vasive, Incorporated201424—
+3K1339056200 / 6250 Ultrasound SystemEsaote, S.p.A.201434—
+3K130887S4C Navigation InstrumentsAesculap Implant System, Inc.201313—
+3K122011Navigation Software Hip-Universal; Navigation Software Hip THR-AesculapBrainlab AG201251
+3K112469General Prupose Localizers and Adapters-New Accessories for Sonowand SystemSonowand AS20122—
+3K111843Acufex Director Application Anatomic Guide SystemSmith & Nephew Inc., Endoscopy Div.20110—
+3K110204Brainlab TraumaBrainlab AG201127—
+3K103400Fluoromap Software, 9 Fluorodisc (Belt), 12 Fluoro Disc (Belt), Close Tube ClipStryker Corporation20115—
+3K1031526250 Ultrasound SytemsEsaote, S.p.A.201135—
+3K093206Orthomap 3D 1.1 ModuleStryker Corp.20100—
+3K100038Disposable Reflective Marker SpheresBrainlab AG201023
+3K100931Mylabtwice, Model 6200Esaote, S.p.A.201046—
+3K093118Brainlab Knee ArthroscopyBrainlab AG20100—
+3K092467Vectorvision Cranial, Vectorvision Ent, Kolibri Cranial, Kolibri Ent, Cranial Essential…Brainlab AG201010Class I
+3K093425Mako Surgical Corp Robotic Arm Interactive Orthopedic System-ThaMako Surgical Corp.2010112
+3K092619Etrax Needle System, Etrax Variable Angle Needle Guidance System, Virtutrax Universal…Civco20096117
+3K091000KneekgEmovi20090—
+3K091998Robotic Arm Interactive Orthopedic System-HipMako Surgical Corp.200912—
+3K092497Smith & Nephew Pigalileo Screw Targeting System, Version 1.1Smith & Nephew, Inc.200977—
+3K083644Mako Surgical Tactile Guidance System-HipMako Surgical Corp.200913—
+3K091009MY LABS25 Gold/MYLAB30 Gold Cardiovascular Model 7340, MY LAB70/MY LAB70XVISION/MYLAB60…Esaote, S.p.A.200951—
+3K083483Brainlab Hip Unlimited, CI Hip UnlimitedBrainlab AG200970—
+3K080886Iplan RT ImageBrainlab AG200833—
+3K080608Digital LightboxBrainlab AG20086—
+3K072716Vector Vision HipBrainlab AG200784—
+3K062086NavivisionBrainlab AG200677—
+3K053159Vectorvision SpineBrainlab AG20061551
+3K053610AbarisTraxtal Technologies, Inc.20062783
+3K053164Iplan FlowBrainlab AG20061—
+3K060121Biomet Pre-Calibrated Computer Aided Surgery Navigation Instruments for Hip ApplicationsBiomet Manufacturing Corp20060—
+3K060468Vectorvision HipBrainlab AG2006154—
+3K052966CI Knee, CI MI TKRBrainlab AG200654—
+3K053127IPLANBrainlab AG200654—
+3K052220Iplan RT FibertrackingBrainlab AG200534—
+3K041899Vectorvision Uni-KneeBrainlab AG2004133—
+4K262253Lantern Knee Navigation Unit (406000-03);Lantern Hip Navigation Unit (502000-03)Orthalign, Inc.20260—
+4K231897NeuroAlign softwareMedivis, Inc.20250—
+4K251317SOLOPASS 2.0 SystemIntravent Medical Partners20250—
+4K243053Navient Image Guided Navigation System (ENT) (955-NC-NC)Claronav20250—
+4K223288Cranial Navigation, Navigation Software Cranial, Navigation Software Craniofacial…Brainlab AG20230—
+4K221618Spine & Trauma Navigation, Spine Navigation, Navigation Software Spine & Trauma…Brainlab AG20226—
+4K201435Molecular Flow SimulationsTherataxis, LLC20210—
+4K203115ARVIS Surgical Navigation SystemInsight Medical Systems, Inc.202132
+4K200376Navbit Sprint System- Supine Registration, Navbit Sprint Kit - Lateral RegistrationNavbit Pty, Ltd.20201—
+4K192703Cranial Image Guided Surgery System, Navigation Software Cranial, Navigation Software…Brainlab AG20203—
+4K201174TruDi CuretteAcclarent, Inc.20200—
+4K193307HIP7Brainlab AG20200—
+4K193580VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Left, VERASENSE for Zimmer Biomet Persona…Orthosensor, Inc.20201—
+4K191597Stealth Autoguide System, Midas Rex Legend Depth Stop SystemMedtronic Navigation, Inc.201941
+4K182524GALILEO Spine Alignment Monitoring SystemMiRus, LLC20190—