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
K181041 7D Surgical Inc. 7D Surgical System Cranial Application 08/08/2018
K833484 A. PATIL, M.D. COMPUTED TOMOGRAPHY ORIENTED ROTARY ARC 12/29/1983
K924348 AD-TECH MEDICAL INSTRUMENT CORP. AD-TECH'S BRAIN BIOPSY NEEDLE FOR STEREOTAXIC 11/23/1992
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
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
K082060 BRAINLAB AG CRANIAL IMAGE GUIDED SURGERY SYSTEM 05/08/2009
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
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
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
K915819 BRAINLAB MEDIZINISCHE COMPUTERSYSTEME GMBH BRAINSCAN WORKSTATION 05/11/1992
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
K953568 Codman & Shurtleff, Inc. CODMAN FIDUCIAL MARKER SYSTEM 02/29/1996
K935456 COMPASS INTL., INC. REGULUS MEASUREMENT UNIT 10/13/1995
K964229 COMPASS INTL., INC. REGULUS NAVIGATOR 08/19/1997
K823424 CONCEPT, INC. MENISCECTOMY TRAY #9715 03/17/1983
K900200 COOK, INC. COOK STEREOTAXIC GUIDE 05/31/1990
K915791 CORITECHS, INC. CORITAXIC MULTI-MODAL STEREOTAXI WORKSTATION 07/10/1992
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
K851973 DIASONICS, INC. DIASONICS, BERGER STEREOTACTIC NEOROBIOPSY 07/26/1985
K861629 DOWNS SURGICAL LTD. KOMAI CT-STEREOTACTIC APPARATUS AND ACCESSORIES 08/12/1986
K790502 DYONICS, INC. DYONICS STEROTOXIC POSITIONER 04/05/1979
K051724 EBI, L.P. ACUMEN IMAGE GUIDED SURGICAL SYSTEM 07/19/2005
K031732 EBI, L.P. EBI ACUMEN SURGICAL NAVIGATION SYSTEM 10/15/2003
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
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
K943468 ELEKTA INSTRUMENTS, INC. LEKSELL SURGIPLAN 01/20/1995
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
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
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
K946033 LEIBINGER GMBH LEIBINGER STEREOPLAN PLUS STEROTACTIC TREATMENT PLAN ING SOFTWARE PACKAGE 09/01/1995
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
K852477 MAYO CLINIC KELLY-GROERSS-KALL CT STEROTACTIC ADAPTATION SYS 07/30/1985
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
K851659 MEDCO PRODUCTS, CO., INC. SKULL MOUNTED STEREOTACTIC SURGICAL DEVICE 07/01/1985
K874833 MEDICAL EQUIPMENT DEVELOPMENT CO., INC. ARC ADAPTER ASSEMBLY 03/03/1988
K901670 MEDICAL EQUIPMENT DEVELOPMENT CO., INC. GNOMOS STEREOTACTIC DEVICE 07/03/1990
K894263 MEDICAL INSTRUMENTATION & DIAGNOSTICS CORP.(MIDCO) CASS SYSTEM 09/01/1989
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
K092239 MEDTECH S.A. ROSA SURGICAL DEVICE, MODEL ROSA 1.1 11/17/2009
K101791 MEDTECH SAS ROSA SURGICAL DEVICE 09/23/2010
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
K162655 MEDTRONIC NAVIGATION, INC. StealthConnect Remote Viewing, Planning and Collaboration System 04/21/2017
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
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
K142505 MRI INTERVENTIONS, INC. ClearPoint System 10/21/2015
K160434 MRI INTERVENTIONS, INC. ClearPoint System 03/17/2016
K852662 NEUROSURGICAL DEVICES, INC. GOUDA FRAME FOR STEREOTACTIC NEUROSURGERY 08/21/1985
K050377 NEW BUSINESS DEVELOPMENT, LLC NBD HEAD SCREW 04/07/2005
K931991 NOMOS CORP. GNOMOS STEREOTACTIC SYSTEM W/ NONINVASIVE FIXATION 08/20/1993
K955397 NOMOS CORP. MAYFIELD-ACCISS WORKSTATION 04/30/1996
K936019 NOMOS CORP. NOMOS STEREOTACTIC BIOPSY INSTRUMENTS 03/22/1994
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
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
K000310 PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. VOYAGER 6.0 SOFTWARE OPTION 02/15/2000
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
K020298 PLUS ORTHOPEDICS GALILEO CAS/NAV TKR SYSTEM 05/20/2002
K070731 PLUS ORTHOPEDICS AG PIGALILEO TOTAL HIP REPLACEMENT (THR) SYSTEM 07/31/2007
K061362 PLUS ORTHOPEDICS AG PIGALILEO TOTAL KNEE REPLACEMENT (TKR) SYSTEM 10/06/2006
K031196 PRAXIM SURGETICS ORTHO KNEELOGICS NAVIGATION SYSTEM 06/07/2005
K081232 PRAXIM TOTAL KNEE SURGETICS NAVIGATION SYSTEM WITH PRAXITELES 08/06/2008
K063408 PRAXIM MEDIVISION, SA CTLOGICS NAVIGATIONS SYSTEMS 02/28/2007
K062146 PRAXIM S.A UNI KNEE SURGETICS NAVIGATION SYSTEM 08/21/2006
K053542 PRAXIM SA SURGETICS ORTHO OSTEOLOGICS NAVIGATION SYSTEM 04/10/2006
K072267 PRAXIM SA TOTAL HIP SURGETICS NAVIGATION SYSTEM 12/10/2007
K060282 PRAXIM SA TOTAL KNEE SURGETICS NAVIGATION SYSTEM 04/10/2006
K812744 PROGRESS MANKIND TECHNOLOGY LEVY BIOTAC #LX001 BIOPSY PROBE HOLDER 12/03/1981
K831329 PROGRESS MANKIND TECHNOLOGY PMT VAXIOM STEREOTACTIC SYS #FX001 06/15/1983
K944463 RADIONICS SOFTWARE APPLICATIONS, INC. CRW-1 SYSTEM 10/26/1995
K961844 RADIONICS SOFTWARE APPLICATIONS, INC. OPERATING ARM SYSTEM (OAS) [WITH CT AND MR IMAGES] 10/23/1996
K974602 RADIONICS SOFTWARE APPLICATIONS, INC. OPTICAL TRACKING SYSTEM (OTS) 04/21/1998
K964801 RADIONICS SOFTWARE APPLICATIONS, INC. OPTICAL TRACKING SYSTEM (OTS) 06/02/1997
K990326 RADIONICS SOFTWARE APPLICATIONS, INC. OPTICAL TRACKING SYSTEM MICROSCOPE MODULE II, MODEL OTS MMII 03/04/1999
K946252 RADIONICS SOFTWARE APPLICATIONS, INC. STEREOPLAN 03/14/1995
K010548 RADIONICS, A DIVISION OF TYCO HEALTHCARE GROUP LP MODIFICATION TO OPTICAL TRACKING SYSTEM (OTS) 03/12/2001
K032054 RADIONICS, A DIVISION OF TYCO HEALTHCARE GROUP LP RADIONICS NASHOLD BIOPSY NEEDLE - SINGLE USE 09/15/2003
K980584 RADIONICS, INC. ATLASPLAN 05/18/1998
K961858 RADIONICS, INC. COSGROVE DEPTH ELECTRODE KIT(CDEK) 08/07/1996
K992721 RADIONICS, INC. COSMAN ROBERT WELLS FUNCTIONAL PROBE MICRODRIVE 09/10/1999
K001431 RADIONICS, INC. MODIFICATION TO OPTICAL TRACKING SYSTEM (OTS) 05/17/2000
K984245 RADIONICS, INC. NON-INVASIVE DYNAMIC REFERENCE FRAME (DRF) FOR OPTICAL TRACKING SYSTEM, MODEL OTS 12/18/1998
K001950 RADIONICS, INC. OPTICAL TRACKING SYSTEM (OTS) 07/26/2000
K990632 RADIONICS, INC. OPTICAL TRACKING SYSTEM (OTS) 04/29/1999
K983669 RADIONICS, INC. OPTICAL TRACKING SYSTEM WITH SURFACE MATCHING MODULE, MODEL OTS 11/18/1998
K983603 RADIONICS, INC. REFLECTIVE SPHERE STANDARD PROBE AND REFLECTIVE SPHERE DYNAMIC REFERENCE FRAME 11/10/1998
K981213 RADIONICS, INC. UNIVERSAL INSTRUMENT REGISTRATION (UIR) MICROSCOPE MODULE I 07/01/1998
K982364 RADIONICS, INC. WIRELESS STANDARD PROBE, DYNAMIC REFERENCE FRAME (DRF) 08/05/1998
K830999 RAPID MACHINE & TOOL CORP. DAP II BIOPSY GUIDE 07/12/1983
K132755 RENISHAW MAYFIELD SARL NEUROMATE FRAMELESS GEN II 04/29/2014
K181706 Renishaw Mayfield Sarl neuromate Gen III 07/26/2018
K180206 Renishaw Mayfield Sarl neuromate Gen III 04/24/2018
K163666 Rensihaw plc neuro inspire 09/15/2017
K061224 ROBODENT GMBH LAPDOC I 09/05/2006
K881132 SANDSTROM TRADE & TECHNOLOGY, INC. LAITINEN'S TRIGEMINUS STEREOGUIDE 08/09/1988
K881131 SANDSTROM TRADE & TECHNOLOGY, INC. THE LAITINEN STEREOTACTIC SYSTEM 08/01/1988
K041897 SCHAERER MAYFIELD USA, INC. MAYFIELD ACCISS II IMAGE GUIDED SURGERY SYSTEM, MODEL 2002-01 06/01/2005
K993501 SCIENTIFIC TOOLS, INC. 3D1 MICROPOSITIONING HEADSTAGE 11/22/1999
K014113 SIEMENS MEDICAL SOLUTIONS USA, INC. ENDOMAP 06/14/2002
K080875 SMITH & NEPHEW, INC. PIGALILEO 4TH GENERATION SYSTEM 07/18/2008
K082267 SMITH & NEPHEW, INC. PIGALILEO CAS, VERSION 4.0 AND TKR BASE, VERSION 2.1 10/29/2008
K083565 SMITH & NEPHEW, INC. PIGALILEO TOTAL HIP REPLACEMENT (THR) SOFTWARE APPLICATION V3.0 02/20/2009
K033341 SMITH & NEPHEW, INC. SMITH & NEPHEW IMAGE GUIDED SURGICAL INSTRUMENTS FOR HIP APPLICATIONS 09/10/2004
K021798 SMITH & NEPHEW, INC. SMITH & NEPHEW IMAGE GUIDED SURGICAL INSTRUMENTS FOR HIP APPLICATIONS 12/09/2002
K012938 SMITH & NEPHEW, INC. SMITH & NEPHEW IMAGE GUIDED SURGICAL INSTRUMENTS FOR KNEE APPLICATIONS 02/08/2002
K022460 SMITH & NEPHEW, INC. SMITH & NEPHEW IMAGE GUIDED SURGICAL SYSTEM FOR KNEE APPLICATIONS 08/19/2002
K021815 SMITH & NEPHEW, INC. SMITH & NEPHEW IMAGE SURGICAL INSTRUMENTS FOR TRAUMA APPLICATIONS 10/17/2002
K112469 SONOWAND AS GENERAL PRUPOSE LOCALIZERS AND ADAPTERS-NEW ACCESSORIES FOR SONOWAND SYSTEM 03/23/2012
K083597 SONOWAND AS SONOWAND INVITE 09/25/2009
K854475 SPARTA INSTRUMENT CORP. GHAJAR INTRAVENTRICULAR CATHETER GUIDE 02/20/1986
K901883 STEREOTACTIC IMAGE SYSTEMS, INC. STEREOTACTIC ONE MEDICAL APPLICATION SOFTWARE 03/07/1991
K862220 STEREOTACTIC MEDICAL SYSTEMS, INC. COMPASS CT STEREOTACTIC ADAPTATION SYSTEM 06/18/1986
K871046 STEREOTACTIC MEDICAL SYSTEMS, INC. COMPASS STEREOTACTIC POSITIONING SYSTEM 05/08/1987
K002732 STRYKER CORP. STRYKER NAVIGATION SYSTEM - ENT MODULE 10/02/2000
K993239 STRYKER CORP. STRYKER NAVIGATION SYSTEM - NEURO MODULE, MODEL 6000-XXX-XXX 01/18/2000
K072271 STRYKER CORP. STRYKER NAVIGATION SYSTEM INFINITUS HIP RESURFACING MODULE 12/18/2007
K010204 STRYKER CORP. STRYKER NAVIGATION SYSTEM-KNEE MODULE 08/31/2001
K080450 STRYKER CORP. STRYKER POWER TOOL NAVIGATOR ATTACHMENT 07/17/2008
K991706 STRYKER CORP. VIRTUOSO-STEREOTAXIC PLANNING SOFTWARE 12/07/1999
K131214 STRYKER CORPORATE CRANIAL MAP NEURO 10/18/2013
K130874 STRYKER CORPORATE STRYKER NAV3I PLATFORM 09/27/2013
K162929 Stryker Corporation Stryker Navigation System with CranialMap software application, Stryker CranialMap Planning software application, Stryker CranialMask Tracker 02/22/2017
K003486 STRYKER INSTRUMENTS STEREOTACTIC FRAME BASED SYSTEM 05/17/2001
K062640 STRYKER INSTRUMENTS STRYKER NAVIGATION SYSTEM - CRANIAL MODULE, MODEL 6000-650-000 12/14/2006
K050615 STRYKER INSTRUMENTS STRYKER NAVIGATION SYSTEM - CT-BASED HIP MODULE, MODEL 6007-621-000 04/21/2005
K022365 STRYKER INSTRUMENTS STRYKER NAVIGATION SYSTEM - HIP MODULE 01/22/2003
K003111 STRYKER INSTRUMENTS STRYKER NAVIGATION SYSTEM-SPINE & FLUOROSCOPY MODULES 01/04/2001
K004027 STRYKER INSTRUMENTS STRYKER REMOTE SURGICAL PLANNING SYSTEM 01/24/2001
K012380 STRYKER LEIBINGER MODIFICATION TO: STRYKER NAVIGATION SYSTEM, STRYKER FLUOROSCOPY SYSTEM,VIRTUAL FLUOROSCOPY 12/03/2001
K022579 STRYKER LEIBINGER STRYKER NAVIGATION SYSTEM-KNEE MODULE 06/02/2003
K150301 Stryker Leibinger GmbH & Co. KG - Navigation NavSuite3 Kit 07/08/2015
K001642 SURGICAL INSIGHTS, INC. INSIGHT IMAGE GUIDED SURGICAL SYSTEM 09/12/2000
K994421 SURGICAL NAVIGATION SPECIALISTS, INC. SNN STEREOTAXIC PLANNING APPLICATION; SNN STEREOTACTIC APPLICATION 02/23/2000
K010542 SURGICAL NAVIGATION SPECIALISTS, INC. SNN SYSTEM INCLUDING THE TOMOGUIDE OPTION 05/08/2001
K992457 SURGICAL NAVIGATION SPECIALISTS, INC. SNN SYSTEM WITH OLIVIER DOUBLE CHUCK SUPPORT ARM OPTION 08/27/1999
K990214 SURGICAL NAVIGATION TECHNOLOGIES, INC. FLUORONAV MODULE FOR THE STEALTHSTATION SYSTEM 04/22/1999
K971247 SURGICAL NAVIGATION TECHNOLOGIES, INC. SNT DISPOSABLE BIOPSY NEEDLE 06/16/1997
K971675 SURGICAL NAVIGATION TECHNOLOGIES, INC. SNT STEREOTACTIC LOCALIZATION SYSTEM 07/14/1997
K954276 SURGICAL NAVIGATION TECHNOLOGIES, INC. STEALTHSTATION 01/24/1996
K972398 SURGICAL NAVIGATION TECHNOLOGIES, INC. STEALTHSTATION PASSIVE INSTRUMENT OPTION 09/16/1997
K974161 SURGICAL NAVIGATION TECHNOLOGIES, INC. STEALTHSTATION SYSTEM 11/21/1997
K974187 SURGICAL NAVIGATION TECHNOLOGIES, INC. STEALTHSTATION SYSTEM 01/21/1998
K963173 SURGICAL NAVIGATION TECHNOLOGIES, INC. STEALTHSTATION SYSTEM 10/25/1996
K983670 SURGICAL NAVIGATION TECHNOLOGIES, INC. STEALTHSTATION SYSTEM 01/14/1999
K981686 SURGICAL NAVIGATION TECHNOLOGIES, INC. STEALTHSTATION SYSTEM DIGITIZER CHANGE 08/07/1998
K983397 SURGICAL NAVIGATION TECHNOLOGIES, INC. STEALTHSTATION TREATMENT GUIDANCE PLAFFORM 12/04/1998
K992461 SURGICAL NAVIGATION TECHNOLOGIES, INC. STEALTHSTATION TREATMENT GUIDANCE PLATFORM 02/22/2000
K981684 SURGICAL NAVIGATION TECHNOLOGIES, INC. STEALTHSTATION TREATMENT GUIDANCE PLATFORM 08/06/1998
K981768 SURGICAL NAVIGATION TECHNOLOGIES, INC. STEALTHSTATION TREATMENT GUIDANCE PLATFORM 11/23/1998
K992927 SURGICAL NAVIGATION TECHNOLOGIES, INC. STEALTHSTATION TREATMENT GUIDANCE PLATFORM 12/29/1999
K981809 SURGICAL SOLUTIONS, INC. CAROLINE GUIDE 08/14/1998
K973277 SURGICAL SOLUTIONS, INC. CAROLINE GUIDE/DELIA LOCALIZER 11/17/1997
K160523 SYNAPTIVE MEDICAL INC. BrightMatter Guide with BrightMatter Pointer 06/24/2016
K153281 SYNAPTIVE MEDICAL INC. BrightMatter Guide with Surface Trace Registration 03/30/2016
K142024 SYNAPTIVE MEDICAL INC. BRIGHTMATTER NAVIGATION SYSTEM 04/02/2015
K122211 SYNTHES SPINE SYNTHES NAVIGABLE PEDICLE PREPARATION INSTRUMENTS 12/17/2012
K110644 TATRAMED SPOL. S.R.O. PRAEZIS PLUS 05/24/2012
K874693 TIPAL INSTRUMENTS LTD. OBT STEREOTACTIC SYSTEM 03/11/1988
K823675 TODAY'S MACHINING & DESIGN, INC. FRONING GUIDANCE SYSTEM #TX-8200 01/05/1983
K811452 TRENT WELLS, INC. BROWN-ROBERTS-WELLS STEREOTAXIC SYTEM 06/02/1981
K180854 Voyager Therapeutics, Inc. Voyager Trajectory Array Guide (V-TAG) 07/23/2018
K010427 WALTER LORENZ SURGICAL, INC. LORENZ FIDUCAIL SCREW 03/15/2001
K872877 WALTER LORENZ SURGICAL, INC. TARGET PROGRAM & EPSON HX-20 COMPUTER 02/12/1988
K894387 WESTERN MEDICAL, LTD. WESTCO MADAYAG PAB NEEDLE 11/07/1989
K002893 Z-KAT, INC. FLUOROLAB PLUS 12/04/2000
K013025 Z-KAT, INC. MODIFICATION TO FLOUROLAB PLUS 10/03/2001
K023975 Z-KAT, INC. VOYAGER LINUX 12/20/2002
K984298 Z-KAT, INC. Z KAT FLUROTACTIC GUIDANCE SYSTEM MKI 06/23/1999
K030764 Z-KAT, INC. Z-BOX 04/24/2003
K060556 ZIMMER INC. BRIGIT SURGICAL DEVICE 07/31/2006
K052425 ZIMMER, INC. ZIMMER COMPUTER ASSISTED SOLUTIONS-ELECTROMAGNETIC AND IMAGELESS KNEE INSTRUMENTATION 12/28/2005
K062228 ZIMMER, INC. ZIMMER HIP COMPUTER ASSISTED SOLUTIONS ELECTROMAGNETIC AND IMAGELESS INSTRUMENTATION 11/08/2006
K033223 ZIMMER, INC. ZIMMER ORTHO GUIDANCE SYSTEMS- HIP INSTRUMENTS 02/18/2004
K033011 ZIMMER, INC. ZIMMER ORTHO GUIDANCE SYSTEMS- KNEE INSTRUMENTS 02/12/2004


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact