FDA 510(k) Applications for Medical Device Product Code "HAW"
(Neurological Stereotaxic Instrument)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K061479 | 3D LINE MEDICAL SYSTEMS S.R.L. | ARGOS | 04/05/2007 |
| K011255 | 3D LINE USA, INC. | 3D LINE STEROTACTIC HARDWARE ACCESSORIES | 12/20/2001 |
| K183276 | 7D Surgical Inc. | 7D Surgical System | 08/07/2019 |
| K181041 | 7D Surgical Inc. | 7D Surgical System Cranial Application | 08/08/2018 |
| K192945 | 7D Surgical Inc. | 7D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application | 11/27/2019 |
| K112094 | AD-TECH MEDICAL INSTRUMENT CORP. | BRAIN BIOPSY NEEDLE | 04/24/2012 |
| K080547 | AESCULAP IMPLANT SYSTEM, INC. | ORTHOPILOT NEXT GENERATION, MODEL FS101-FS106 | 05/23/2008 |
| K072899 | AESCULAP IMPLANT SYSTEMS, INC. | ORTHOPILOT 2 TOTAL HIP ARTHROPLASTY (THA) VERSION 3.0 | 02/06/2008 |
| K050752 | AESCULAP, INC. | AESCULAP ORTHOPILOT 2 THA V 2.0 | 04/27/2005 |
| K013569 | AESCULAP, INC. | ORTHOPILOT 2 | 04/04/2002 |
| K021327 | AESCULAP, INC. | ORTHOPILOT HTO MODULE | 07/25/2002 |
| K013396 | ALPHA OMEGA LTD. | ALPHA DRIVE SYSTEM | 08/07/2002 |
| K141559 | ARC SURGICAL LLC. | V-GUIDE FOR VENTRICULOSTOMIES | 02/27/2015 |
| K041477 | ARMSTRONG HEALTHCARE LIMITED | PATHFINDER | 12/09/2004 |
| K990683 | AXON INSTRUMENTS, INC. | AXON MP-1 MICROPOSITIONER | 11/03/1999 |
| K060121 | BIOMET MANUFACTURING CORP. | BIOMET PRE-CALIBRATED COMPUTER AIDED SURGERY NAVIGATION INSTRUMENTS FOR HIP APPLICATIONS | 03/21/2006 |
| K031337 | BIOMET, INC. | ACUMEN SURGICAL NAVIGATION SYSTEM | 09/15/2003 |
| K031454 | BIOMET, INC. | ACUMEN SURGICAL NAVIGATION SYSTEM | 07/08/2004 |
| K961903 | BIOSENSE, LTD. | MAGELLAN | 08/24/1998 |
| K152764 | BLUE ORTHO | EXACTECH GPS | 07/13/2016 |
| K992916 | BRAINLAB | BRAINLAB STEREOTACTIC ARC | 01/11/2000 |
| K223864 | Brainlab AG | Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial Biopsy, Cirq Alignment Software Cranial sEEG, Varioguide Alignment Software Cranial | 09/09/2023 |
| K223552 | Brainlab AG | Brainlab Elements û Trajectory Planning (2.6), Elements Stereotaxy, Elements Lead Localization, Elements Trajectory Planning Cranial | 04/19/2023 |
| K073615 | BRAINLAB AG | BRAINLAB KNEE ESSENTIAL, BRAINLAB KNEE UNLIMITED CI KNEE, CI KNEE UNLIMITED | 09/05/2008 |
| K070556 | BRAINLAB AG | BRAINSUITE NET | 09/25/2007 |
| K210989 | Brainlab AG | Cirq, Cirq Robotic Alignment System, Cirq Robotic Alignment Module Cranial, Cirq Robotic Alignment Module, Cirq Robotic Alignment Cranial And Spine, CIRQ Robotic Alignment Cranial and Spine System | 11/12/2021 |
| K213989 | Brainlab AG | Cranial EM System | 09/08/2022 |
| K082060 | BRAINLAB AG | CRANIAL IMAGE GUIDED SURGERY SYSTEM | 05/08/2009 |
| K192703 | Brainlab AG | Cranial Image Guided Surgery System, Navigation Software Cranial, Navigation Software ENT, Registration Software Cranial, Automatic Registration 2.0, Ultrasound Navigation Software (BK), Intraoperative Structure Update | 10/08/2020 |
| K223288 | Brainlab AG | Cranial Navigation, Navigation Software Cranial, Navigation Software Craniofacial, Cranial EM System, Automatic Registration iMRI | 07/21/2023 |
| K201752 | Brainlab AG | Disposable Pre-calibrated Suction | 01/29/2021 |
| K020631 | BRAINLAB AG | IPLAN | 09/09/2002 |
| K101627 | BRAINLAB AG | IPLAN | 06/03/2011 |
| K053164 | BRAINLAB AG | IPLAN FLOW | 03/23/2006 |
| K042543 | BRAINLAB AG | IPLAN! DIGITAL TEMPLATING | 05/17/2005 |
| K041330 | BRAINLAB AG | IPLAN! FLOW | 09/22/2004 |
| K014256 | BRAINLAB AG | KOLIBRI IGS SYSTEMS | 07/19/2002 |
| K042391 | BRAINLAB AG | KOLIBRI IMAGE GUIDED SURGERY SYSTEM | 10/19/2004 |
| K042721 | BRAINLAB AG | KOLIBRI SPINE | 04/19/2005 |
| K190250 | Brainlab AG | Microscope Navigation | 09/06/2019 |
| K172820 | Brainlab AG | Microscope Navigation Software | 03/01/2018 |
| K012564 | BRAINLAB AG | MODIFICATION TO: VECTORVISION FRAMELESS BIOPSY SYSTEM | 09/06/2001 |
| K052213 | BRAINLAB AG | NAVIGATION SW HIP 3.1 ON CI | 11/02/2005 |
| K062086 | BRAINLAB AG | NAVIVISION | 09/20/2006 |
| K211544 | Brainlab AG | Trajectory Planning, Elements Trajectory Planning, Elements Lead Localization | 11/03/2021 |
| K080678 | BRAINLAB AG | UNI-KNEE 2.0 | 06/06/2008 |
| K072716 | BRAINLAB AG | VECTOR VISION HIP | 10/12/2007 |
| K042512 | BRAINLAB AG | VECTORVISION ACL | 01/13/2005 |
| K092467 | BRAINLAB AG | VECTORVISION CRANIAL, VECTORVISION ENT, KOLIBRI CRANIAL, KOLIBRI ENT, CRANIAL ESSENTIAL, CRANIAL UNLIMITED | 05/06/2010 |
| K003589 | BRAINLAB AG | VECTORVISION CRANIAL, VECTORVISION SPINAL, VECTORVISION ENT | 05/21/2001 |
| K023651 | BRAINLAB AG | VECTORVISION CRANIAL/ENT | 02/17/2004 |
| K021306 | BRAINLAB AG | VECTORVISION CT-FREE KNEE | 10/25/2002 |
| K060468 | BRAINLAB AG | VECTORVISION HIP | 03/20/2006 |
| K060727 | BRAINLAB AG | VECTORVISION HIP | 08/21/2006 |
| K040368 | BRAINLAB AG | VECTORVISION HIP 3.0 | 08/23/2004 |
| K072573 | BRAINLAB AG | VECTORVISION HIP AND HIP SR | 10/11/2007 |
| K042513 | BRAINLAB AG | VECTORVISION OSTEOTOMY | 02/10/2005 |
| K053159 | BRAINLAB AG | VECTORVISION SPINE | 06/06/2006 |
| K012448 | BRAINLAB AG | VECTORVISION TRAUMA | 03/14/2002 |
| K041899 | BRAINLAB AG | VECTORVISION UNI-KNEE | 10/06/2004 |
| K070106 | BRAINLAB AG | VV FLUORO 3D | 04/23/2007 |
| K952390 | BRAINLAB MED. COMPUTERSYSTEME GMBH | BRAINLAB STEROTATIC HEADRING | 02/02/1996 |
| K983410 | BRAINLAB, AG | @ TARGET | 09/17/1999 |
| K954789 | BRAINLAB, AG | BRAINLAB HEADPINS | 08/12/1996 |
| K052966 | BRAINLAB, AG | CI KNEE, CI MI TKR | 02/13/2006 |
| K031770 | BRAINLAB, AG | CI TKR/UKR | 08/12/2003 |
| K100038 | BRAINLAB, AG | DISPOSABLE REFLECTIVE MARKER SPHERES | 07/14/2010 |
| K053127 | BRAINLAB, AG | IPLAN | 02/09/2006 |
| K041703 | BRAINLAB, AG | IPLAN! | 10/22/2004 |
| K062358 | BRAINLAB, AG | MODIFICATION TO VECTORVISION TRAUMA | 01/17/2007 |
| K010968 | BRAINLAB, AG | VECTORVISION CT/FLUORO | 08/30/2001 |
| K024192 | BRAINLAB, AG | VECTORVISION FLUORO3D | 06/11/2003 |
| K010602 | BRAINLAB, AG | VECTORVISION HIP | 09/12/2001 |
| K063028 | BRAINLAB, AG | VECTORVISION HIP SR | 12/12/2006 |
| K010612 | BRAINLAB, AG | VECTORVISION KNEE | 09/06/2001 |
| K981508 | BRAINLAB, AG | VECTORVISION SPINE MODULE | 10/29/1998 |
| K983831 | BRAINLAB, AG | VECTORVISION2 | 05/19/1999 |
| K003268 | BRAINLAB, AG | Z-TOUCH | 02/22/2001 |
| K962939 | BRAINLAB, INC. | VECTORVISION | 05/22/1997 |
| K965139 | CARL ZEISS, INC. | SURGICAL MICROSCOPE NAVIGATOR (SMN) SYSTEM/SURGICAL TOOL NAVIGATOR (STN) SYSTEM | 04/23/1997 |
| K000171 | CBYON, INC. | CBYON SURGICAL OPERATING SYSTEM (SOS) | 03/13/2000 |
| K012886 | CBYON, INC. | CBYON SYSTEM WITH IMAGE ENHANCED FLUOROSCOPY MODULE | 10/09/2001 |
| K163439 | ClaroNav Inc. | NaviENT | 09/01/2017 |
| K202575 | ClearPoint Neuro, Inc. | ClearPoint Array System | 01/22/2021 |
| K214040 | ClearPoint Neuro, Inc. | ClearPoint Array System (version 1.1) | 04/12/2022 |
| K232102 | ClearPoint Neuro, Inc. | ClearPoint Array System (Version 1.2) | 09/15/2023 |
| K222519 | ClearPoint Neuro, Inc. | ClearPoint System | 09/16/2022 |
| K953568 | Codman & Shurtleff, Inc. | CODMAN FIDUCIAL MARKER SYSTEM | 02/29/1996 |
| K964229 | COMPASS INTL., INC. | REGULUS NAVIGATOR | 08/19/1997 |
| K023424 | DENX ADVANCED DENTAL SYSTEMS | IGI-SYSTEM | 05/09/2003 |
| K052840 | DENX ADVANCED DENTAL SYSTEMS | IGI-SYSTEM | 12/16/2005 |
| K071334 | DEPUY ORTHOPAEDICS, INC. | DEPUY CAS HEMI ASR HIP INSTRUMENTS | 07/02/2007 |
| K052178 | DEPUY ORTHOPAEDICS, INC. | DEPUY CAS HIP INSTRUMENTATION | 10/21/2005 |
| K043223 | DEPUY ORTHOPAEDICS, INC. | DEPUY CAS KNEE INSTRUMENTATION | 03/04/2005 |
| K071135 | DEPUY ORTHOPAEDICS, INC. | DEPUY CI HIP INSTRUMENTATION | 05/23/2007 |
| K051724 | EBI, L.P. | ACUMEN IMAGE GUIDED SURGICAL SYSTEM | 07/19/2005 |
| K031732 | EBI, L.P. | EBI ACUMEN SURGICAL NAVIGATION SYSTEM | 10/15/2003 |
| K210109 | Eemagine Medical Imaging Solutions GmbH | visor2 system | 04/08/2022 |
| K051746 | ELEKTA INSTRUMENT AB | ELEKTA ESARTE FRAME SYSTEM | 07/25/2005 |
| K031999 | ELEKTA INSTRUMENT AB | ELEKTA LEKSELL STEREOTACTIC SYSTEM WITH MR POST KIT | 07/25/2003 |
| K040979 | ELEKTA INSTRUMENT AB | ELEKTA MICRODRIVE, MODEL 916716 | 07/23/2004 |
| K991636 | ELEKTA INSTRUMENT AB | ELEKTA STEREOTACTIC GUIDE | 07/20/1999 |
| K961639 | ELEKTA INSTRUMENT AB | LEKSELL IMAGE GUIDANCE SURGICAL SYSTEM (LIGS) | 07/26/1996 |
| K992882 | ELEKTA INSTRUMENT AB | LEKSELL IMAGE GUIDANCE SURGICAL SYSTEM, VIEW SCOPE, SURGISCOPE,ELEKTA INSIGHT | 09/24/1999 |
| K972324 | ELEKTA INSTRUMENT AB | LEKSELL STEREOTACTIC SYSTEM | 03/02/1998 |
| K080355 | ELEKTA INSTRUMENT AB | LEKSELL STEREOTACTIC SYSTEM WITH REUSABLE FIXATION SCREWS | 05/01/2009 |
| K152558 | ELEKTA INSTRUMENT AB | Leksell Stereotactic System, Injection/ Aspiration Needle Kit | 03/02/2016 |
| K033340 | ELEKTA INSTRUMENT AB | LEKSELL SURGIPLAN WITH IMAGEMERGE | 02/12/2004 |
| K080250 | ELEKTA INSTRUMENT AB | LEKSELL SURGIPLAN, MODEL 1006947 | 05/13/2008 |
| K171123 | Elekta Instrument AB | Leksell Vantage Stereotactic System | 09/15/2017 |
| K190887 | Elekta Instrument AB | Leksell Vantage Stereotactic System | 08/01/2019 |
| K973684 | ELEKTA INSTRUMENT AB | LEKSELL VIEWSCOPE, LEKSELL SURGISCOPE, LEKSELL FREEHAND | 03/31/1998 |
| K031980 | ELEKTA INSTRUMENT AB | MODIFICATION TO LEKSELL STEREOTACTIC SYSTEM | 07/25/2003 |
| K013861 | ELEKTA INSTRUMENT AB | MODIFICATION TO LEKSELL SURGIPLAN WITH ATLASPACE | 12/06/2001 |
| K011992 | FHC, INC. | FHC MICROTARGETING DRIVE SYSTEM | 08/14/2001 |
| K011775 | FHC, INC. | MICRO TARGETING DRIVE SYSTEM | 08/30/2001 |
| K003776 | FHC, INC. | MICROTARGETING DRIVE SYSTEM | 02/23/2001 |
| K092562 | FHC, INC. | MICROTARGETING STAR DRIVE SYSTEM, COMPONENTS | 09/18/2009 |
| K121950 | FHC, INC. | MICROTARGETING XL STAR DRIVE SYSTEM | 07/26/2012 |
| K092192 | FHC, INC. | WAYPOINT STEREOTACTIC SYSTEM | 02/12/2010 |
| K151156 | FIAGON GMBH | Fiagon Navigation System | 04/01/2016 |
| K163209 | FIAGON GMBH | Fiagon Navigation System | 09/14/2017 |
| K132611 | FRED HAER COMPANY, INC. | MICROTABLE SYSTEM | 03/06/2014 |
| K051734 | GE HEALTHCARE TECHNOLOGIES | GE HEALTHCARE INSTA TRAK 3500PLUS/ FLUORO TRAK 9800 PLUS SYSTEM WITH AXCESS BONE PIN, MODEL PART # 1006955 | 11/23/2005 |
| K182000 | Globus Medical Inc. | AQrate Robotic Assistance System | 01/29/2019 |
| K030343 | GYRUS ENT L.L.C. | DIEGO POWERED DISSECTOR HANDPIECE WITH STARLINK IMAGE-GUIDED ADAPTER MOUNTING INTERFACE | 05/02/2003 |
| K961120 | HOWMEDICA LEIBINGER, INC. | MARKER SYSTEM FOR STEREOTAXIC NAVIGATION | 05/10/1996 |
| K053348 | HOWMEDICA OSTEONICS CORP | STRYKER ORTHOPAEDICS RFID INSTRUMENTATION | 08/04/2006 |
| K970865 | I.S.G. TECHNOLOGIES, INC. | ISG FAMILY OF VIEWING WANDS | 06/04/1997 |
| K960714 | I.S.G. TECHNOLOGIES, INC. | ISG VIEWING WAND | 05/29/1996 |
| K993673 | I.S.G. TECHNOLOGIES, INC. | SNN FLUORO NAVIGATION SYSTEM | 12/21/1999 |
| K982570 | I.S.G. TECHNOLOGIES, INC. | SNN SCOUT | 01/13/1999 |
| K022074 | I.Z.I. CORP. | SPHERZ | 08/13/2002 |
| K103192 | ILUMARK GMBH | NAVIGATION MARKER, REFLECTIVE MARKER SPHERES | 02/07/2011 |
| K024201 | IMAGE-GUIDED NEUROLOGICS, INC. | NAVIGUS FIDUCIAL MARKER SYSTEM, MODELS FM-1000, FM-2000 | 03/12/2003 |
| K012719 | IMAGE-GUIDED NEUROLOGICS, INC. | NAVIGUS II MR | 10/22/2001 |
| K012366 | IMAGE-GUIDED NEUROLOGICS, INC. | NAVIGUS II TRAJECTORY GUIDE | 10/01/2001 |
| K023949 | IMAGE-GUIDED NEUROLOGICS, INC. | NAVIGUS II TRAJECTORY GUIDE WITH VERIFICATION RETICULES | 02/25/2003 |
| K022100 | IMAGE-GUIDED NEUROLOGICS, INC. | NAVIGUS MANUAL DISPOSABLE MICRODRIVE WITH DIGITAL DISPLAY, MODELS MI-1000 & MI-1010 | 09/25/2002 |
| K043091 | IMAGE-GUIDED NEUROLOGICS, INC. | NAVIGUS NEXDRIVE, MODEL MI-3000 | 02/07/2005 |
| K040834 | IMAGE-GUIDED NEUROLOGICS, INC. | NAVIGUS PASSIVE PROBE (BL), MODEL NP-2000 | 06/03/2004 |
| K040334 | IMAGE-GUIDED NEUROLOGICS, INC. | NAVIGUS PASSIVE PROBE, MODEL NP-1000 | 10/04/2004 |
| K050772 | IMAGE-GUIDED NEUROLOGICS, INC. | NAVIGUS REUSABLE PASSIVE PROBE, MODEL SP-2000 | 04/21/2005 |
| K011971 | IMAGE-GUIDED NEUROLOGICS, INC. | NAVIGUS TRAJECTORY GUIDE BIOPSY KIT, MODELS BK-7000 AND 8000 | 08/03/2001 |
| K992304 | IMAGE-GUIDED NEUROLOGICS, INC. | NAVIGUS TRAJECTORY GUIDE, MODEL TG-XXXX | 08/27/1999 |
| K033619 | IMAGE-GUIDED NEUROLOGICS, INC. | NAVIGUS UNIBODY FIDUCIAL MARKER SYSTEM, MODEL FM-4000 | 03/02/2004 |
| K990907 | IMAGE-GUIDED NEUROLOGICS, INC. | REMOTE INTRODUCER, MODEL PI-1000 | 08/12/1999 |
| K001192 | IMAGE-GUIDED NEUROLOGICS, INC. | SELF ADHERING NAVIGUS GUIDE | 06/07/2000 |
| K983539 | IMAGE-GUIDED NEUROLOGICS, INC. | TRAJECTORY GUIDE, MODEL # TGX-XXX | 02/12/1999 |
| K143420 | IMRIS, Inc. | SYMBIS Surgical System | 10/30/2015 |
| K160811 | INTEGRA LIFESCIENCES CORPORATION | CRW STEREOTACTIC SYSTEM | 12/06/2016 |
| K991081 | INTEGRATED SURGICAL SYSTEMS, INC. | FRAMELESS NEUROMATE | 06/25/1999 |
| K963256 | INTEGRATED SURGICAL SYSTEMS, S.A. | NEUROMATE STEREOTACTIC SYSTEM | 05/09/1997 |
| K203251 | inTRAvent Medical Partners, LP | SOLOPASS System | 08/27/2021 |
| K140705 | IZI MEDICAL PRODUCTS | NAVIGABLE BRAIN BIOPSY CANNULA SET | 12/05/2014 |
| K142344 | IZI MEDICAL PRODUCTS LLC | DISPOSABLE PASSIVE ACCESSORY FOR MEDTRONIC StealthStation System | 03/20/2015 |
| K143241 | IZI MEDICAL PRODUCTS LLC | MDT Navigable Brain Biopsy Cannula | 04/13/2015 |
| K122096 | KARL STORZ ENDOSCOPY-AMERICA, INC. | KARL STORZ NAVIGATIONPANEL UNIT (NPU) SYSTEM | 09/27/2012 |
| K020764 | KINAMED, INC. | NAVIPRO | 06/03/2002 |
| K033668 | KINAMED, INC. | NAVIPRO KNEE SOFTWARE MODULE | 03/11/2004 |
| K050897 | KINAMED, INC. | NAVIPRO SHOULDER SOFTWARE MODULE | 05/24/2005 |
| K003347 | KINAMED, INC. | ORTHOPILOT | 02/23/2001 |
| K223577 | Localite GmbH | Localite TMS Navigator TS | 04/17/2023 |
| K072806 | MAKO SURGICAL CORP. | MAKO SURGICAL TACTILE GUIDANCE SYSTEM (TGS) | 01/24/2008 |
| K081867 | MAKO SURGICAL CORP. | MAKO SURGICAL TACTILE GUIDANCE SYSTEM VERSION 2.0 | 11/25/2008 |
| K050973 | MAKO SURGICAL CORP. | MODIFICATION TO: VOYAGER LINUX | 05/17/2005 |
| K052851 | MAKO SURGICAL CORP. | VOYAGER LINUX WITH TACTILE GUIDANCE SYSTEM (TGS) | 11/18/2005 |
| K111558 | MATERIALISE N.V. | SURGICASE GUIDE | 03/27/2012 |
| K120812 | MAZOR ROBOTICS LTD | RENAISSANCE | 07/12/2012 |
| K110911 | MAZOR ROBOTICS LTD | RENAISSANCE SYSTEM | 04/28/2011 |
| K113228 | MAZOR ROBOTICS LTD | RENAISSANCE SYSTEM | 12/01/2011 |
| K033413 | MAZOR SURGICAL TECHNOLOGIES LTD. | SPINEASSIST DEVICE | 01/07/2004 |
| K051676 | MAZOR SURGICAL TECHNOLOGIES LTD. | SPINEASSIST DEVICE WITH ADDITIONAL ACCESSORIES | 09/08/2005 |
| K063607 | MAZOR SURGICAL TECHNOLOGIES LTD. | SPINEASSIST SYSTEM | 08/23/2007 |
| K073467 | MAZOR SURGICAL TECHNOLOGIES LTD. | SPINEASSIST SYSTEM | 05/23/2008 |
| K102130 | MAZOR SURGICAL TECHNOLOGIES LTD. | TENZING SYSTEM | 08/26/2010 |
| K100314 | MEDACTA INTERNATIONAL, SA | IMNS MEDACTA NAVIGATION SYSTEM,33.221000US | 03/31/2010 |
| K003699 | MEDIVISION (U.S.A.), INC. | MEDIVISION IGS SYSTEM | 02/27/2001 |
| K151359 | MEDTECH S.A. | ROSA Brain | 12/18/2015 |
| K172444 | MEDTECH S.A. | ROSA BRAIN (v3.0.0.5) | 03/28/2018 |
| K182417 | MEDTECH S.A. | ROSA ONE Brain Application | 02/07/2019 |
| K200511 | Medtech S.A. | ROSA ONE Brain application | 05/29/2020 |
| K092239 | MEDTECH S.A. | ROSA SURGICAL DEVICE, MODEL ROSA 1.1 | 11/17/2009 |
| K214065 | Medtech S.A.S | ROSA ONE Brain application | 05/04/2022 |
| K231103 | Medtech S.A.S | ROSA ONE Brain Application | 07/20/2023 |
| K101791 | MEDTECH SAS | ROSA SURGICAL DEVICE | 09/23/2010 |
| K212397 | Medtronic Navigation | StealthStation S8 Cranial v2.0 | 12/22/2021 |
| K190672 | Medtronic Navigation Inc | StealthStation Synergy Cranial S7 Software v.2.2.8, StealthStation Cranial Software v3.1.1 | 07/31/2019 |
| K201175 | Medtronic Navigation Inc. | StealthStation Cranial Software v1.3.0 | 06/03/2020 |
| K061248 | MEDTRONIC NAVIGATION, INC. | AXIEM IMAGELESS HIP MODULE FOR THE STEALTHSTATION SYSTEM | 08/31/2006 |
| K162604 | MEDTRONIC NAVIGATION, INC. | Cranial Reducing Tubes | 12/30/2016 |
| K052623 | MEDTRONIC NAVIGATION, INC. | IMAGELESS HIP MODULE FOR THE STEALTHSTATION SYSTEM | 03/02/2006 |
| K050651 | MEDTRONIC NAVIGATION, INC. | MEDTRONIC ORTHOPAEDIC TRAUMA APPLICATION | 07/27/2005 |
| K130608 | MEDTRONIC NAVIGATION, INC. | QUADCUT | 08/07/2013 |
| K191597 | Medtronic Navigation, Inc. | Stealth Autoguide System, Midas Rex Legend Depth Stop System | 11/01/2019 |
| K162655 | MEDTRONIC NAVIGATION, INC. | StealthConnect Remote Viewing, Planning and Collaboration System | 04/21/2017 |
| K203639 | Medtronic Navigation, Inc. | StealthStation Cranial Software v1.3.2 | 01/13/2021 |
| K133444 | MEDTRONIC NAVIGATION, INC. | STEALTHSTATION S7 / I7 / FUSION NAVIGATION SYSTEMS, AXIEM NAVIGATION SYSTEM | 07/25/2014 |
| K162309 | MEDTRONIC NAVIGATION, INC. | StealthStation S8 System Platforms and StealthStation Cranial Software | 03/31/2017 |
| K153660 | MEDTRONIC NAVIGATION, INC. | StealthStation System with Cranial Software | 09/14/2016 |
| K141833 | MEDTRONIC NAVIGATION, INC. | STYLET, 23CM, SKULL-MOUNT PATIENT TRACKER, NON-INVASIVE PATIENT TRACKER, TRACER POINTER, TOUCH-N-GO POINTER, NAVIGATION | 03/25/2015 |
| K150216 | MEDTRONIC NAVIGATION, INC. | Synergy Cranial | 06/11/2015 |
| K221087 | Medtronic Navigation, Inc. | Synergy Cranial v2.2.9, StealthStation Cranial v3.1.4 | 06/10/2022 |
| K001153 | MEDTRONIC SURGICAL NAVIGATION | MODIFICATION TO STEATHSTATION TREATMENT GUIDANCE PLATFORM | 05/03/2000 |
| K001801 | MEDTRONIC SURGICAL NAVIGATION | STEATHSTATION TREATMENT GUIDANCE PLATFORM | 06/30/2000 |
| K051029 | MEDTRONIC SURGICAL NAVIGATION | STELTHSTATION WIRELESS SURGEON MOUSE | 06/08/2005 |
| K022126 | MEDTRONIC SURGICAL NAVIGATION TECHNOLOGIES | CATHETER INTRODUCER FOR THE STEALTHSTATION SYSTEM | 01/03/2003 |
| K021980 | MEDTRONIC SURGICAL NAVIGATION TECHNOLOGIES | HIP MODULE FOR THE STEALTHSTATION SYSTEM | 11/19/2002 |
| K030552 | MEDTRONIC SURGICAL NAVIGATION TECHNOLOGIES | IMAGELESS KNEE MODULE FOR THE STEALTHSTATION SYSTEM | 03/19/2003 |
| K012937 | MEDTRONIC SURGICAL NAVIGATION TECHNOLOGIES | KNEE MODULE FOR THE STEALTHSTATION SYSTEM | 01/25/2002 |
| K043088 | MEDTRONIC SURGICAL NAVIGATION TECHNOLOGIES | MEDTRONIC SNT STEALTHSTATION AXIEM IMAGELESS KNEE MODULE | 01/05/2005 |
| K030106 | MEDTRONIC SURGICAL NAVIGATION TECHNOLOGIES | STEALTHSTATION SYSTEM ADVANCED CONTOUR REGISTRATION SOFTWARE MODULE | 02/12/2003 |
| K001284 | MEDTRONIC SURGICAL NAVIGATION TECHNOLOGIES | STEALTHSTATION SYSTEM GOLDENEYE MICRO-MAGNETIC TRACKING SYSTEM | 06/12/2000 |
| K022414 | MEDTRONIC SURGICAL NAVIGATION TECHNOLOGIES | STEALTHSTATION SYSTEM THREE DIMENSIONAL C-ARM INTERFACE | 08/14/2002 |
| K050438 | MEDTRONIC SURGICAL NAVIGATION TECHNOLOGIES | STEALTHSTATION SYSTEM UPDATE | 06/02/2005 |
| K003201 | MEDTRONIC SURGICAL NAVIGATION TECHNOLOGIES | STEALTHSTATION TREATMENT GUIDANCE PLATFORM | 12/12/2000 |
| K020338 | MEDTRONIC SURGICAL NAVIGATION TECHNOLOGIES | STEALTHSTATION WITH FLUOROMERGE SOFTWARE | 02/27/2002 |
| K090240 | MONTERIS MEDICAL | MONTERIS MEDICAL UFO | 08/06/2009 |
| K200079 | MRI Interventions, Inc | ClearPoint System and Accessories | 02/13/2020 |
| K142505 | MRI INTERVENTIONS, INC. | ClearPoint System | 10/21/2015 |
| K160434 | MRI INTERVENTIONS, INC. | ClearPoint System | 03/17/2016 |
| K191400 | MRI Interventions, Inc. | Voyager Trajectory Array Guide (V-TAG) | 06/21/2019 |
| K231392 | NaviNetics Inc. | NaviNetics Reusable Stereotactic System (NN1000) | 07/14/2023 |
| K210700 | NaviNetics, Inc | NaviNetics D1 Stereotactic System | 06/17/2021 |
| K050377 | NEW BUSINESS DEVELOPMENT, LLC | NBD HEAD SCREW | 04/07/2005 |
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