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
K955397 NOMOS CORP. MAYFIELD-ACCISS WORKSTATION 04/30/1996
K033621 NORTHERN DIGITAL, INC. NDI PASSIVE SPHERES 01/27/2004
K090190 NUCLEMED S.A. WIN-NEUS STEREOTACTIC SURGERY TREATMENT PLANNING SYSTEM 10/09/2009
K013257 NUVASIVE, INC. HEMI-ARC SURGICAL NAVIGATOR 10/30/2001
K982244 OHIO MEDICAL INSTRUMENT CO., INC. MAYFIELD ACCISS OPTICAL SYSTEM 09/23/1998
K013428 OHIO MEDICAL INSTRUMENT CO., INC. MAYFIELD/ACCISS OPERATING ARM SYSTEM AND MAYFIELD/OPTICAL ACCISS SYSTEM 04/04/2002
K991267 OHIO MEDICAL INSTRUMENT CO., INC. SPINE APPLICATIONS FOR THE MAYFIELD/ACCISS OPERATING ARM AND OPTICAL ACCISS SYSTEMS MODULE, MAYFIELD/ACCISS SPINE RING A 07/12/1999
K992843 OHIO MEDICAL INSTRUMENT CO., INC. THE MAYFIELD / ACCISS SYSTEM WITH WINDOWS NT FOR CRANIAL SURGERY, THE MAYFIELD / OPTICAL ACCISS SYSTEM WITH WINDOWS NT F 11/02/1999
K981315 ORTHOSOFT, INC. NAVITRACK 07/09/1998
K071714 ORTHOSOFT, INC. NAVITRACK SYSTEM - OS UNICONDYLAR KNEE UNIVERSAL, MODEL# PRO-06003 07/20/2007
K041369 ORTHOSOFT, INC. NAVITRACK SYSTEM - S&N IMAGE FREE HIP, MODEL PRO-03017 06/22/2004
K043536 ORTHOSOFT, INC. NAVITRACK SYSTEM - S&N IMAGE FREE KNEE 01/14/2005
K032917 ORTHOSOFT, INC. NAVITRACK SYSTEM - TOTAL HIP REPLACEMENT CT-FREE 10/21/2003
K022364 ORTHOSOFT, INC. NAVITRACK SYSTEM TOTAL HIP REPLACEMENT,MODEL 900.200 02/04/2003
K071929 ORTHOSOFT, INC. NAVITRACK SYSTEM- PARTIAL HIP RESURFACING UNIVERSAL 09/19/2007
K031156 ORTHOSOFT, INC. NAVITRACK SYSTEM-FLUOROSPINE, MODEL 900.005 05/09/2003
K021760 ORTHOSOFT, INC. NAVITRACK SYSTEM-OPTICAL TKR CT-LESS, MODEL 900.120 08/27/2002
K060336 ORTHOSOFT, INC. NAVITRACK SYSTEM-OS KNEE UNIVERSAL, MODEL PRO-05002 04/28/2006
K030827 ORTHOSOFT, INC. NAVITRACK SYSTEM: TOTAL HIP REPLACEMENT CT-FREE CUP, MODEL 900.204 05/23/2003
K002053 ORTHOSOFT, INC. NAVITRAK SYSTEM-OPTICAL OPTION, MODEL 900.004 08/03/2000
K140868 ORTHOVITA, INC. STRYKER KWIC NEEDLE 06/05/2014
K060808 PAJUNK GMBH MEDIZINTECHNOLOGIE BRAINPRO, BRAINPRO ACCESS 07/25/2006
K220897 PAJUNK GmbH Medizintechnologie Disposable Brain Biopsy Needle 2.0 08/17/2022
K230201 Pajunk GmbH Medizintechnologie Disposable Pre-calibrated Brain Biopsy Needle 2.0 02/22/2023
K980820 PHILIPS MEDICAL SYSTEMS, INC. PHILIPS EASYGUIDE 10/13/1998
K981480 PHILIPS MEDICAL SYSTEMS, INC. PHILIPS EASYGUIDE 01/28/1999
K961834 PHILIPS MEDICAL SYSTEMS, INC. PHILIPS EASYGUIDE NEURO 11/08/1996
K963221 PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. OPTICAL DIGITIZER OPTION FOR VIEW POINT 01/10/1997
K970604 PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. VIEWPOINT - 3.0 SOFTWARE 05/19/1997
K991256 PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. VIEWPOINT ENT/ORTHOPEDIC OPTION 10/08/1999
K990860 PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. VIEWPOINT MICROSCOPE OPTION 03/30/1999
K990868 PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. VIEWPOINT PASSIVE TOOL OPTION 03/30/1999
K983764 PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. VIEWPOINT TOOLS- STERRAD 07/08/1999
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