Neurological Stereotaxic Instrument
The Neurological Stereotaxic Instrument is a frame-based or frameless guidance device used in neurosurgery to precisely target specific intracranial coordinates for biopsy, electrode placement, ablation, or other procedures using a three-dimensional coordinate system referenced to external landmarks. It is classified as a Class 2 device (moderate risk), requiring 510(k) premarket notification. The product code is HAW under regulation 21 CFR 882.4560 in the Neurology specialty. No third-party review flag applies.
Basic Information
- Product Code
- HAW
- Device Class
- FDA class 2
- Regulation Number
- 882.4560
- Medical Specialty
- Neurology
- Review Panel
- NE
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 418 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K250505 | EZ-FIDUCIALS | Jul 09, 2025 | Substantially Equivalent | Phasor Health, LLC |
| K242575 | Stereotaxic Guiding Surgical Devices, NaoTrac S | May 23, 2025 | Substantially Equivalent | Brain Navi Biotechnology Co., Ltd. |
| K241327 | Navient Image Guide Navigation System (955-NC-NC), Cranial | Feb 05, 2025 | Substantially Equivalent | ClaroNav |
| K243698 | Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignment Software Cranial Biopsy; Cirq Alignment Software Cranial sEEG; VarioGuide Alignment Software Cranial; Cirq Alignment Software Cranial LITT | Jan 28, 2025 | Substantially Equivalent | Brainlab AG |
| K243657 | ClearPoint System (Software Version 3.0) | Jan 24, 2025 | Substantially Equivalent | ClearPoint Neuro, Inc. |
| K241333 | Geniant Cranial (Navigated Neurosurgical Positioning Robot) | Jan 17, 2025 | Substantially Equivalent | Koh Young Technology Inc. |
| K242480 | FLASH EVD System (10-0002) | Dec 27, 2024 | Substantially Equivalent | 7D Surgical ULC |
| K242351 | Zeta Cranial Navigation System (ZNS131-US) | Oct 04, 2024 | Substantially Equivalent | Zeta Surgical Inc. |
| K233703 | Bone Anchor (NGS-BA-01) | Apr 26, 2024 | Substantially Equivalent | ClearPoint Neuro Inc. |
| K233155 | ClearPointer Optical Navigation Wand | Jan 12, 2024 | Substantially Equivalent | ClearPoint Neuro Inc. |
| K233144 | ClearPoint Bone Screw Fiducials | Jan 12, 2024 | Substantially Equivalent | ClearPoint Neuro Inc. |
| K233141 | SmartFrame OR | Jan 12, 2024 | Substantially Equivalent | ClearPoint Neuro Inc. |
| K233903 | Zeta Cranial Navigation System (ZNS131-US) | Jan 10, 2024 | Substantially Equivalent | Zeta Surgical Inc |
| K233243 | ClearPoint System (Software Version 2.2) | Nov 27, 2023 | Substantially Equivalent | ClearPoint Neuro Inc. |
| K231976 | StealthStation Cranial Software, v3.1.5 (9735585) | Oct 19, 2023 | Substantially Equivalent | Medtronic Navigation, Inc. |
| K232102 | ClearPoint Array System (Version 1.2) | Sep 15, 2023 | Substantially Equivalent | ClearPoint Neuro, Inc. |
| K223864 | Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial Biopsy, Cirq Alignment Software Cranial sEEG, Varioguide Alignment Software Cranial | Sep 09, 2023 | Substantially Equivalent | Brainlab AG |
| K230661 | Zeta Cranial Navigation System | Sep 08, 2023 | Substantially Equivalent | Zeta Surgical |
| K223288 | Cranial Navigation, Navigation Software Cranial, Navigation Software Craniofacial, Cranial EM System, Automatic Registration iMRI | Jul 21, 2023 | Substantially Equivalent | Brainlab AG |
| K231103 | ROSA ONE Brain Application | Jul 20, 2023 | Substantially Equivalent | Medtech S.A.S |
| K231392 | NaviNetics Reusable Stereotactic System (NN1000) | Jul 14, 2023 | Substantially Equivalent | NaviNetics Inc. |
| K220072 | Sinobot X1 | Jun 18, 2023 | Substantially Equivalent | Sinovation (Beijing) Medical Technology Co., Ltd |
| K223552 | Brainlab Elements Trajectory Planning (2.6), Elements Stereotaxy, Elements Lead Localization, Elements Trajectory Planning Cranial | Apr 19, 2023 | Substantially Equivalent | Brainlab AG |
| K223577 | Localite TMS Navigator TS | Apr 17, 2023 | Substantially Equivalent | Localite GmbH |
| K221544 | MagVenture TMS Atlas Neuro Navigation System | Mar 17, 2023 | Substantially Equivalent | Tonica Elektronik A/S |
| K230201 | Disposable Pre-calibrated Brain Biopsy Needle 2.0 | Feb 22, 2023 | Substantially Equivalent | Pajunk GmbH Medizintechnologie |
| K212194 | Stryker Q Guidance System with Cranial Guidance Software, CranialMask Tracker and Microscope Tracker, Passive Optical Navigation Instruments, Mayfield Base with Articulating Arm, and Navigated Biopsy Needle, Electromagnetic Navigation Instruments, Precision Targeting System | Feb 16, 2023 | Substantially Equivalent | Stryker Corporation |
| K222519 | ClearPoint System | Sep 16, 2022 | Substantially Equivalent | ClearPoint Neuro, Inc. |
| K213989 | Cranial EM System | Sep 08, 2022 | Substantially Equivalent | Brainlab AG |
| K220897 | Disposable Brain Biopsy Needle 2.0 | Aug 17, 2022 | Substantially Equivalent | PAJUNK GmbH Medizintechnologie |
| K221087 | Synergy Cranial v2.2.9, StealthStation Cranial v3.1.4 | Jun 10, 2022 | Substantially Equivalent | Medtronic Navigation, Inc. |
| K214065 | ROSA ONE Brain application | May 04, 2022 | Substantially Equivalent | Medtech S.A.S |
| K214040 | ClearPoint Array System (version 1.1) | Apr 12, 2022 | Substantially Equivalent | ClearPoint Neuro, Inc. |
| K210109 | visor2 system | Apr 08, 2022 | Substantially Equivalent | Eemagine Medical Imaging Solutions GmbH |
| K212397 | StealthStation S8 Cranial v2.0 | Dec 22, 2021 | Substantially Equivalent | Medtronic Navigation |
| K201435 | Molecular Flow Simulations | Dec 03, 2021 | Substantially Equivalent | Therataxis, LLC |
| K210989 | 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 | Nov 12, 2021 | Substantially Equivalent | Brainlab AG |
| K211544 | Trajectory Planning, Elements Trajectory Planning, Elements Lead Localization | Nov 03, 2021 | Substantially Equivalent | Brainlab AG |
| K203251 | SOLOPASS System | Aug 27, 2021 | Substantially Equivalent | inTRAvent Medical Partners, LP |
| K210700 | NaviNetics D1 Stereotactic System | Jun 17, 2021 | Substantially Equivalent | NaviNetics, Inc |
| K201752 | Disposable Pre-calibrated Suction | Jan 29, 2021 | Substantially Equivalent | Brainlab AG |
| K202575 | ClearPoint Array System | Jan 22, 2021 | Substantially Equivalent | ClearPoint Neuro, Inc. |
| K203639 | StealthStation Cranial Software v1.3.2 | Jan 13, 2021 | Substantially Equivalent | Medtronic Navigation, Inc. |
| K192703 | 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 | Oct 08, 2020 | Substantially Equivalent | Brainlab AG |
| K201175 | StealthStation Cranial Software v1.3.0 | Jun 03, 2020 | Substantially Equivalent | Medtronic Navigation Inc. |
| K200511 | ROSA ONE Brain application | May 29, 2020 | Substantially Equivalent | Medtech S.A. |
| K191422 | Neural Navigator | Apr 06, 2020 | Substantially Equivalent | Soterix Medical, Inc. |
| K200079 | ClearPoint System and Accessories | Feb 13, 2020 | Substantially Equivalent | MRI Interventions, Inc |
| K192945 | 7D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application | Nov 27, 2019 | Substantially Equivalent | 7D Surgical Inc. |
| K191597 | Stealth Autoguide System, Midas Rex Legend Depth Stop System | Nov 01, 2019 | Substantially Equivalent | Medtronic Navigation, Inc. |
| K190250 | Microscope Navigation | Sep 06, 2019 | Substantially Equivalent | Brainlab AG |
| K183276 | 7D Surgical System | Aug 07, 2019 | Substantially Equivalent | 7D Surgical Inc. |
| K190887 | Leksell Vantage Stereotactic System | Aug 01, 2019 | Substantially Equivalent | Elekta Instrument AB |
| K190672 | StealthStation Synergy Cranial S7 Software v.2.2.8, StealthStation Cranial Software v3.1.1 | Jul 31, 2019 | Substantially Equivalent | Medtronic Navigation Inc |
| K183325 | Modus Nav | Jul 14, 2019 | Substantially Equivalent | Synaptive Medical Inc. |
| K191400 | Voyager Trajectory Array Guide (V-TAG) | Jun 21, 2019 | Substantially Equivalent | MRI Interventions, Inc. |
| K182417 | ROSA ONE Brain Application | Feb 07, 2019 | Substantially Equivalent | MEDTECH S.A. |
| K182000 | AQrate Robotic Assistance System | Jan 29, 2019 | Substantially Equivalent | Globus Medical Inc. |
| K181041 | 7D Surgical System Cranial Application | Aug 08, 2018 | Substantially Equivalent | 7D Surgical Inc. |
| K181706 | neuromate Gen III | Jul 26, 2018 | Substantially Equivalent | Renishaw Mayfield Sarl |
| K180854 | Voyager Trajectory Array Guide (V-TAG) | Jul 23, 2018 | Substantially Equivalent | Voyager Therapeutics, Inc. |
| K180206 | neuromate Gen III | Apr 24, 2018 | Substantially Equivalent | Renishaw Mayfield Sarl |
| K172444 | ROSA BRAIN (v3.0.0.5) | Mar 28, 2018 | Substantially Equivalent | MEDTECH S.A. |
| K172820 | Microscope Navigation Software | Mar 01, 2018 | Substantially Equivalent | Brainlab AG |
| K171123 | Leksell Vantage Stereotactic System | Sep 15, 2017 | Substantially Equivalent | Elekta Instrument AB |
| K163666 | neuro inspire | Sep 15, 2017 | Substantially Equivalent | Rensihaw plc |
| K163209 | Fiagon Navigation System | Sep 14, 2017 | Substantially Equivalent | FIAGON GMBH |
| K163439 | NaviENT | Sep 01, 2017 | Substantially Equivalent | ClaroNav Inc. |
| K162655 | StealthConnect Remote Viewing, Planning and Collaboration System | Apr 21, 2017 | Substantially Equivalent | MEDTRONIC NAVIGATION, INC. |
| K162309 | StealthStation S8 System Platforms and StealthStation Cranial Software | Mar 31, 2017 | Substantially Equivalent | MEDTRONIC NAVIGATION, INC. |
| K162929 | Stryker Navigation System with CranialMap software application, Stryker CranialMap Planning software application, Stryker CranialMask Tracker | Feb 22, 2017 | Substantially Equivalent | Stryker Corporation |
| K162604 | Cranial Reducing Tubes | Dec 30, 2016 | Substantially Equivalent | MEDTRONIC NAVIGATION, INC. |
| K160811 | CRW STEREOTACTIC SYSTEM | Dec 06, 2016 | Substantially Equivalent | INTEGRA LIFESCIENCES CORPORATION |
| K153660 | StealthStation System with Cranial Software | Sep 14, 2016 | Substantially Equivalent | MEDTRONIC NAVIGATION, INC. |
| K152764 | EXACTECH GPS | Jul 13, 2016 | Substantially Equivalent | BLUE ORTHO |
| K160523 | BrightMatter Guide with BrightMatter Pointer | Jun 24, 2016 | Substantially Equivalent | SYNAPTIVE MEDICAL INC. |
| K151156 | Fiagon Navigation System | Apr 01, 2016 | Substantially Equivalent | FIAGON GMBH |
| K153281 | BrightMatter Guide with Surface Trace Registration | Mar 30, 2016 | Substantially Equivalent | SYNAPTIVE MEDICAL INC. |
| K160434 | ClearPoint System | Mar 17, 2016 | Substantially Equivalent | MRI INTERVENTIONS, INC. |
| K152558 | Leksell Stereotactic System, Injection/ Aspiration Needle Kit | Mar 02, 2016 | Substantially Equivalent | ELEKTA INSTRUMENT AB |
| K151359 | ROSA Brain | Dec 18, 2015 | Substantially Equivalent | MEDTECH S.A. |
| K143420 | SYMBIS Surgical System | Oct 30, 2015 | Substantially Equivalent | IMRIS, Inc. |
| K142505 | ClearPoint System | Oct 21, 2015 | Substantially Equivalent | MRI INTERVENTIONS, INC. |
| K150301 | NavSuite3 Kit | Jul 08, 2015 | Substantially Equivalent | Stryker Leibinger GmbH & Co. KG - Navigation |
| K150216 | Synergy Cranial | Jun 11, 2015 | Substantially Equivalent | MEDTRONIC NAVIGATION, INC. |
| K143241 | MDT Navigable Brain Biopsy Cannula | Apr 13, 2015 | Substantially Equivalent | IZI MEDICAL PRODUCTS LLC |
| K142024 | BRIGHTMATTER NAVIGATION SYSTEM | Apr 02, 2015 | Substantially Equivalent | SYNAPTIVE MEDICAL INC. |
| K141833 | STYLET, 23CM, SKULL-MOUNT PATIENT TRACKER, NON-INVASIVE PATIENT TRACKER, TRACER POINTER, TOUCH-N-GO POINTER, NAVIGATION | Mar 25, 2015 | Substantially Equivalent | MEDTRONIC NAVIGATION, INC. |
| K142344 | DISPOSABLE PASSIVE ACCESSORY FOR MEDTRONIC StealthStation System | Mar 20, 2015 | Substantially Equivalent | IZI MEDICAL PRODUCTS LLC |
| K141559 | V-GUIDE FOR VENTRICULOSTOMIES | Feb 27, 2015 | Substantially Equivalent | ARC SURGICAL LLC. |
| K140705 | NAVIGABLE BRAIN BIOPSY CANNULA SET | Dec 05, 2014 | Substantially Equivalent | IZI MEDICAL PRODUCTS |
| K133444 | STEALTHSTATION S7 / I7 / FUSION NAVIGATION SYSTEMS, AXIEM NAVIGATION SYSTEM | Jul 25, 2014 | Substantially Equivalent | MEDTRONIC NAVIGATION, INC. |
| K140868 | STRYKER KWIC NEEDLE | Jun 05, 2014 | Substantially Equivalent | ORTHOVITA, INC. |
| K132755 | NEUROMATE FRAMELESS GEN II | Apr 29, 2014 | Substantially Equivalent | RENISHAW MAYFIELD SARL |
| K132611 | MICROTABLE SYSTEM | Mar 06, 2014 | Substantially Equivalent | FRED HAER COMPANY, INC. |
| K131214 | CRANIAL MAP NEURO | Oct 18, 2013 | Substantially Equivalent | STRYKER CORPORATE |
| K130874 | STRYKER NAV3I PLATFORM | Sep 27, 2013 | Substantially Equivalent | STRYKER CORPORATE |
| K130608 | QUADCUT | Aug 07, 2013 | Substantially Equivalent | MEDTRONIC NAVIGATION, INC. |
| K122211 | SYNTHES NAVIGABLE PEDICLE PREPARATION INSTRUMENTS | Dec 17, 2012 | Substantially Equivalent | SYNTHES SPINE |
| K122096 | KARL STORZ NAVIGATIONPANEL UNIT (NPU) SYSTEM | Sep 27, 2012 | Substantially Equivalent | KARL STORZ ENDOSCOPY-AMERICA, INC. |
| K121950 | MICROTARGETING XL STAR DRIVE SYSTEM | Jul 26, 2012 | Substantially Equivalent | FHC, INC. |
| K120812 | RENAISSANCE | Jul 12, 2012 | Substantially Equivalent | MAZOR ROBOTICS LTD |
| K110644 | PRAEZIS PLUS | May 24, 2012 | Substantially Equivalent | TATRAMED SPOL. S.R.O. |
| K112094 | BRAIN BIOPSY NEEDLE | Apr 24, 2012 | Substantially Equivalent | AD-TECH MEDICAL INSTRUMENT CORP. |
| K111558 | SURGICASE GUIDE | Mar 27, 2012 | Substantially Equivalent | MATERIALISE N.V. |
| K112469 | GENERAL PRUPOSE LOCALIZERS AND ADAPTERS-NEW ACCESSORIES FOR SONOWAND SYSTEM | Mar 23, 2012 | Substantially Equivalent | SONOWAND AS |
| K113228 | RENAISSANCE SYSTEM | Dec 01, 2011 | Substantially Equivalent | MAZOR ROBOTICS LTD |
| K101627 | IPLAN | Jun 03, 2011 | Substantially Equivalent | BRAINLAB AG |
| K110911 | RENAISSANCE SYSTEM | Apr 28, 2011 | Substantially Equivalent | MAZOR ROBOTICS LTD |
| K103192 | NAVIGATION MARKER, REFLECTIVE MARKER SPHERES | Feb 07, 2011 | Substantially Equivalent | ILUMARK GMBH |
| K101791 | ROSA SURGICAL DEVICE | Sep 23, 2010 | Substantially Equivalent | MEDTECH SAS |
| K102130 | TENZING SYSTEM | Aug 26, 2010 | Substantially Equivalent | MAZOR SURGICAL TECHNOLOGIES LTD. |
| K100038 | DISPOSABLE REFLECTIVE MARKER SPHERES | Jul 14, 2010 | Substantially Equivalent | BRAINLAB, AG |
| K092467 | VECTORVISION CRANIAL, VECTORVISION ENT, KOLIBRI CRANIAL, KOLIBRI ENT, CRANIAL ESSENTIAL, CRANIAL UNLIMITED | May 06, 2010 | Substantially Equivalent | BRAINLAB AG |
| K100314 | IMNS MEDACTA NAVIGATION SYSTEM,33.221000US | Mar 31, 2010 | Substantially Equivalent | MEDACTA INTERNATIONAL, SA |
| K092192 | WAYPOINT STEREOTACTIC SYSTEM | Feb 12, 2010 | Substantially Equivalent | FHC, INC. |
| K092239 | ROSA SURGICAL DEVICE, MODEL ROSA 1.1 | Nov 17, 2009 | Substantially Equivalent | MEDTECH S.A. |
| K090190 | WIN-NEUS STEREOTACTIC SURGERY TREATMENT PLANNING SYSTEM | Oct 09, 2009 | Substantially Equivalent | NUCLEMED S.A. |
| K083597 | SONOWAND INVITE | Sep 25, 2009 | Substantially Equivalent | SONOWAND AS |
| K092562 | MICROTARGETING STAR DRIVE SYSTEM, COMPONENTS | Sep 18, 2009 | Substantially Equivalent | FHC, INC. |
| K090240 | MONTERIS MEDICAL UFO | Aug 06, 2009 | Substantially Equivalent | MONTERIS MEDICAL |
| K082060 | CRANIAL IMAGE GUIDED SURGERY SYSTEM | May 08, 2009 | Substantially Equivalent | BRAINLAB AG |
| K080355 | LEKSELL STEREOTACTIC SYSTEM WITH REUSABLE FIXATION SCREWS | May 01, 2009 | Substantially Equivalent | ELEKTA INSTRUMENT AB |
| K083565 | PIGALILEO TOTAL HIP REPLACEMENT (THR) SOFTWARE APPLICATION V3.0 | Feb 20, 2009 | Substantially Equivalent | SMITH & NEPHEW, INC. |
| K081867 | MAKO SURGICAL TACTILE GUIDANCE SYSTEM VERSION 2.0 | Nov 25, 2008 | Substantially Equivalent | MAKO SURGICAL CORP. |
| K082267 | PIGALILEO CAS, VERSION 4.0 AND TKR BASE, VERSION 2.1 | Oct 29, 2008 | Substantially Equivalent | SMITH & NEPHEW, INC. |
| K073615 | BRAINLAB KNEE ESSENTIAL, BRAINLAB KNEE UNLIMITED CI KNEE, CI KNEE UNLIMITED | Sep 05, 2008 | Substantially Equivalent | BRAINLAB AG |
| K081232 | TOTAL KNEE SURGETICS NAVIGATION SYSTEM WITH PRAXITELES | Aug 06, 2008 | Substantially Equivalent | PRAXIM |
| K080875 | PIGALILEO 4TH GENERATION SYSTEM | Jul 18, 2008 | Substantially Equivalent | SMITH & NEPHEW, INC. |
| K080450 | STRYKER POWER TOOL NAVIGATOR ATTACHMENT | Jul 17, 2008 | Substantially Equivalent | STRYKER CORP. |
| K080678 | UNI-KNEE 2.0 | Jun 06, 2008 | Substantially Equivalent | BRAINLAB AG |
| K080547 | ORTHOPILOT NEXT GENERATION, MODEL FS101-FS106 | May 23, 2008 | Substantially Equivalent | AESCULAP IMPLANT SYSTEM, INC. |
| K073467 | SPINEASSIST SYSTEM | May 23, 2008 | Substantially Equivalent | MAZOR SURGICAL TECHNOLOGIES LTD. |
| K080250 | LEKSELL SURGIPLAN, MODEL 1006947 | May 13, 2008 | Substantially Equivalent | ELEKTA INSTRUMENT AB |
| K072899 | ORTHOPILOT 2 TOTAL HIP ARTHROPLASTY (THA) VERSION 3.0 | Feb 06, 2008 | Substantially Equivalent | AESCULAP IMPLANT SYSTEMS, INC. |
| K072806 | MAKO SURGICAL TACTILE GUIDANCE SYSTEM (TGS) | Jan 24, 2008 | Substantially Equivalent | MAKO SURGICAL CORP. |
| K072271 | STRYKER NAVIGATION SYSTEM INFINITUS HIP RESURFACING MODULE | Dec 18, 2007 | Substantially Equivalent | STRYKER CORP. |
| K072267 | TOTAL HIP SURGETICS NAVIGATION SYSTEM | Dec 10, 2007 | Substantially Equivalent | PRAXIM SA |
| K072716 | VECTOR VISION HIP | Oct 12, 2007 | Substantially Equivalent | BRAINLAB AG |
| K072573 | VECTORVISION HIP AND HIP SR | Oct 11, 2007 | Substantially Equivalent | BRAINLAB AG |
| K070556 | BRAINSUITE NET | Sep 25, 2007 | Substantially Equivalent | BRAINLAB AG |
| K071929 | NAVITRACK SYSTEM- PARTIAL HIP RESURFACING UNIVERSAL | Sep 19, 2007 | Substantially Equivalent | ORTHOSOFT, INC. |
| K063607 | SPINEASSIST SYSTEM | Aug 23, 2007 | Substantially Equivalent | MAZOR SURGICAL TECHNOLOGIES LTD. |
| K070731 | PIGALILEO TOTAL HIP REPLACEMENT (THR) SYSTEM | Jul 31, 2007 | Substantially Equivalent | PLUS ORTHOPEDICS AG |
| K071714 | NAVITRACK SYSTEM - OS UNICONDYLAR KNEE UNIVERSAL, MODEL# PRO-06003 | Jul 20, 2007 | Substantially Equivalent | ORTHOSOFT, INC. |
| K071334 | DEPUY CAS HEMI ASR HIP INSTRUMENTS | Jul 02, 2007 | Substantially Equivalent | DEPUY ORTHOPAEDICS, INC. |
| K071135 | DEPUY CI HIP INSTRUMENTATION | May 23, 2007 | Substantially Equivalent | DEPUY ORTHOPAEDICS, INC. |
| K070106 | VV FLUORO 3D | Apr 23, 2007 | Substantially Equivalent | BRAINLAB AG |
| K061479 | ARGOS | Apr 05, 2007 | Substantially Equivalent | 3D LINE MEDICAL SYSTEMS S.R.L. |
| K063408 | CTLOGICS NAVIGATIONS SYSTEMS | Feb 28, 2007 | Substantially Equivalent | PRAXIM MEDIVISION, SA |
| K062358 | MODIFICATION TO VECTORVISION TRAUMA | Jan 17, 2007 | Substantially Equivalent | BRAINLAB, AG |
| K062640 | STRYKER NAVIGATION SYSTEM - CRANIAL MODULE, MODEL 6000-650-000 | Dec 14, 2006 | Substantially Equivalent | STRYKER INSTRUMENTS |
| K063028 | VECTORVISION HIP SR | Dec 12, 2006 | Substantially Equivalent | BRAINLAB, AG |
| K062228 | ZIMMER HIP COMPUTER ASSISTED SOLUTIONS ELECTROMAGNETIC AND IMAGELESS INSTRUMENTATION | Nov 08, 2006 | Substantially Equivalent | ZIMMER, INC. |
| K061362 | PIGALILEO TOTAL KNEE REPLACEMENT (TKR) SYSTEM | Oct 06, 2006 | Substantially Equivalent | PLUS ORTHOPEDICS AG |
| K062086 | NAVIVISION | Sep 20, 2006 | Substantially Equivalent | BRAINLAB AG |
| K061224 | LAPDOC I | Sep 05, 2006 | Substantially Equivalent | ROBODENT GMBH |
| K061248 | AXIEM IMAGELESS HIP MODULE FOR THE STEALTHSTATION SYSTEM | Aug 31, 2006 | Substantially Equivalent | MEDTRONIC NAVIGATION, INC. |
| K062146 | UNI KNEE SURGETICS NAVIGATION SYSTEM | Aug 21, 2006 | Substantially Equivalent | PRAXIM S.A |
| K060727 | VECTORVISION HIP | Aug 21, 2006 | Substantially Equivalent | BRAINLAB AG |
| K053348 | STRYKER ORTHOPAEDICS RFID INSTRUMENTATION | Aug 04, 2006 | Substantially Equivalent | HOWMEDICA OSTEONICS CORP |
| K060556 | BRIGIT SURGICAL DEVICE | Jul 31, 2006 | Substantially Equivalent | ZIMMER INC. |
| K060808 | BRAINPRO, BRAINPRO ACCESS | Jul 25, 2006 | Substantially Equivalent | PAJUNK GMBH MEDIZINTECHNOLOGIE |
| K053159 | VECTORVISION SPINE | Jun 06, 2006 | Substantially Equivalent | BRAINLAB AG |
| K060336 | NAVITRACK SYSTEM-OS KNEE UNIVERSAL, MODEL PRO-05002 | Apr 28, 2006 | Substantially Equivalent | ORTHOSOFT, INC. |
| K060282 | TOTAL KNEE SURGETICS NAVIGATION SYSTEM | Apr 10, 2006 | Substantially Equivalent | PRAXIM SA |
| K053542 | SURGETICS ORTHO OSTEOLOGICS NAVIGATION SYSTEM | Apr 10, 2006 | Substantially Equivalent | PRAXIM SA |
| K053164 | IPLAN FLOW | Mar 23, 2006 | Substantially Equivalent | BRAINLAB AG |
| K060121 | BIOMET PRE-CALIBRATED COMPUTER AIDED SURGERY NAVIGATION INSTRUMENTS FOR HIP APPLICATIONS | Mar 21, 2006 | Substantially Equivalent | BIOMET MANUFACTURING CORP. |
| K060468 | VECTORVISION HIP | Mar 20, 2006 | Substantially Equivalent | BRAINLAB AG |
| K052623 | IMAGELESS HIP MODULE FOR THE STEALTHSTATION SYSTEM | Mar 02, 2006 | Substantially Equivalent | MEDTRONIC NAVIGATION, INC. |
| K052966 | CI KNEE, CI MI TKR | Feb 13, 2006 | Substantially Equivalent | BRAINLAB, AG |
| K053127 | IPLAN | Feb 09, 2006 | Substantially Equivalent | BRAINLAB, AG |
| K052425 | ZIMMER COMPUTER ASSISTED SOLUTIONS-ELECTROMAGNETIC AND IMAGELESS KNEE INSTRUMENTATION | Dec 28, 2005 | Substantially Equivalent | ZIMMER, INC. |
| K052840 | IGI-SYSTEM | Dec 16, 2005 | Substantially Equivalent | DENX ADVANCED DENTAL SYSTEMS |
| K051734 | GE HEALTHCARE INSTA TRAK 3500PLUS/ FLUORO TRAK 9800 PLUS SYSTEM WITH AXCESS BONE PIN, MODEL PART # 1006955 | Nov 23, 2005 | Substantially Equivalent | GE HEALTHCARE TECHNOLOGIES |
| K052851 | VOYAGER LINUX WITH TACTILE GUIDANCE SYSTEM (TGS) | Nov 18, 2005 | Substantially Equivalent | MAKO SURGICAL CORP. |
| K052213 | NAVIGATION SW HIP 3.1 ON CI | Nov 02, 2005 | Substantially Equivalent | BRAINLAB AG |
| K052178 | DEPUY CAS HIP INSTRUMENTATION | Oct 21, 2005 | Substantially Equivalent | DEPUY ORTHOPAEDICS, INC. |
| K051676 | SPINEASSIST DEVICE WITH ADDITIONAL ACCESSORIES | Sep 08, 2005 | Substantially Equivalent | MAZOR SURGICAL TECHNOLOGIES LTD. |
| K050651 | MEDTRONIC ORTHOPAEDIC TRAUMA APPLICATION | Jul 27, 2005 | Substantially Equivalent | MEDTRONIC NAVIGATION, INC. |
| K051746 | ELEKTA ESARTE FRAME SYSTEM | Jul 25, 2005 | Substantially Equivalent | ELEKTA INSTRUMENT AB |
| K051724 | ACUMEN IMAGE GUIDED SURGICAL SYSTEM | Jul 19, 2005 | Substantially Equivalent | EBI, L.P. |
| K051029 | STELTHSTATION WIRELESS SURGEON MOUSE | Jun 08, 2005 | Substantially Equivalent | MEDTRONIC SURGICAL NAVIGATION |
| K031196 | SURGETICS ORTHO KNEELOGICS NAVIGATION SYSTEM | Jun 07, 2005 | Substantially Equivalent | PRAXIM |
| K050438 | STEALTHSTATION SYSTEM UPDATE | Jun 02, 2005 | Substantially Equivalent | MEDTRONIC SURGICAL NAVIGATION TECHNOLOGIES |
| K041897 | MAYFIELD ACCISS II IMAGE GUIDED SURGERY SYSTEM, MODEL 2002-01 | Jun 01, 2005 | Substantially Equivalent | SCHAERER MAYFIELD USA, INC. |
| K050897 | NAVIPRO SHOULDER SOFTWARE MODULE | May 24, 2005 | Substantially Equivalent | KINAMED, INC. |
| K050973 | MODIFICATION TO: VOYAGER LINUX | May 17, 2005 | Substantially Equivalent | MAKO SURGICAL CORP. |
| K042543 | IPLAN! DIGITAL TEMPLATING | May 17, 2005 | Substantially Equivalent | BRAINLAB AG |
| K050752 | AESCULAP ORTHOPILOT 2 THA V 2.0 | Apr 27, 2005 | Substantially Equivalent | AESCULAP, INC. |
| K050772 | NAVIGUS REUSABLE PASSIVE PROBE, MODEL SP-2000 | Apr 21, 2005 | Substantially Equivalent | IMAGE-GUIDED NEUROLOGICS, INC. |
| K050615 | STRYKER NAVIGATION SYSTEM - CT-BASED HIP MODULE, MODEL 6007-621-000 | Apr 21, 2005 | Substantially Equivalent | STRYKER INSTRUMENTS |
| K042721 | KOLIBRI SPINE | Apr 19, 2005 | Substantially Equivalent | BRAINLAB AG |
| K050377 | NBD HEAD SCREW | Apr 07, 2005 | Substantially Equivalent | NEW BUSINESS DEVELOPMENT, LLC |
| K043223 | DEPUY CAS KNEE INSTRUMENTATION | Mar 04, 2005 | Substantially Equivalent | DEPUY ORTHOPAEDICS, INC. |
| K042513 | VECTORVISION OSTEOTOMY | Feb 10, 2005 | Substantially Equivalent | BRAINLAB AG |
| K043091 | NAVIGUS NEXDRIVE, MODEL MI-3000 | Feb 07, 2005 | Substantially Equivalent | IMAGE-GUIDED NEUROLOGICS, INC. |
| K043536 | NAVITRACK SYSTEM - S&N IMAGE FREE KNEE | Jan 14, 2005 | Substantially Equivalent | ORTHOSOFT, INC. |
| K042512 | VECTORVISION ACL | Jan 13, 2005 | Substantially Equivalent | BRAINLAB AG |
| K043088 | MEDTRONIC SNT STEALTHSTATION AXIEM IMAGELESS KNEE MODULE | Jan 05, 2005 | Substantially Equivalent | MEDTRONIC SURGICAL NAVIGATION TECHNOLOGIES |
| K041477 | PATHFINDER | Dec 09, 2004 | Substantially Equivalent | ARMSTRONG HEALTHCARE LIMITED |
| K041703 | IPLAN! | Oct 22, 2004 | Substantially Equivalent | BRAINLAB, AG |
| K042391 | KOLIBRI IMAGE GUIDED SURGERY SYSTEM | Oct 19, 2004 | Substantially Equivalent | BRAINLAB AG |
| K041899 | VECTORVISION UNI-KNEE | Oct 06, 2004 | Substantially Equivalent | BRAINLAB AG |
| K040334 | NAVIGUS PASSIVE PROBE, MODEL NP-1000 | Oct 04, 2004 | Substantially Equivalent | IMAGE-GUIDED NEUROLOGICS, INC. |
| K041330 | IPLAN! FLOW | Sep 22, 2004 | Substantially Equivalent | BRAINLAB AG |
| K033341 | SMITH & NEPHEW IMAGE GUIDED SURGICAL INSTRUMENTS FOR HIP APPLICATIONS | Sep 10, 2004 | Substantially Equivalent | SMITH & NEPHEW, INC. |
| K040368 | VECTORVISION HIP 3.0 | Aug 23, 2004 | Substantially Equivalent | BRAINLAB AG |
| K040979 | ELEKTA MICRODRIVE, MODEL 916716 | Jul 23, 2004 | Substantially Equivalent | ELEKTA INSTRUMENT AB |
| K031454 | ACUMEN SURGICAL NAVIGATION SYSTEM | Jul 08, 2004 | Substantially Equivalent | BIOMET, INC. |
| K041369 | NAVITRACK SYSTEM - S&N IMAGE FREE HIP, MODEL PRO-03017 | Jun 22, 2004 | Substantially Equivalent | ORTHOSOFT, INC. |
| K040834 | NAVIGUS PASSIVE PROBE (BL), MODEL NP-2000 | Jun 03, 2004 | Substantially Equivalent | IMAGE-GUIDED NEUROLOGICS, INC. |
| K033668 | NAVIPRO KNEE SOFTWARE MODULE | Mar 11, 2004 | Substantially Equivalent | KINAMED, INC. |
| K033619 | NAVIGUS UNIBODY FIDUCIAL MARKER SYSTEM, MODEL FM-4000 | Mar 02, 2004 | Substantially Equivalent | IMAGE-GUIDED NEUROLOGICS, INC. |
| K033223 | ZIMMER ORTHO GUIDANCE SYSTEMS- HIP INSTRUMENTS | Feb 18, 2004 | Substantially Equivalent | ZIMMER, INC. |
| K023651 | VECTORVISION CRANIAL/ENT | Feb 17, 2004 | Substantially Equivalent | BRAINLAB AG |
| K033340 | LEKSELL SURGIPLAN WITH IMAGEMERGE | Feb 12, 2004 | Substantially Equivalent | ELEKTA INSTRUMENT AB |
| K033011 | ZIMMER ORTHO GUIDANCE SYSTEMS- KNEE INSTRUMENTS | Feb 12, 2004 | Substantially Equivalent | ZIMMER, INC. |
| K033621 | NDI PASSIVE SPHERES | Jan 27, 2004 | Substantially Equivalent | NORTHERN DIGITAL, INC. |
| K033413 | SPINEASSIST DEVICE | Jan 07, 2004 | Substantially Equivalent | MAZOR SURGICAL TECHNOLOGIES LTD. |
| K032917 | NAVITRACK SYSTEM - TOTAL HIP REPLACEMENT CT-FREE | Oct 21, 2003 | Substantially Equivalent | ORTHOSOFT, INC. |
| K031732 | EBI ACUMEN SURGICAL NAVIGATION SYSTEM | Oct 15, 2003 | Substantially Equivalent | EBI, L.P. |
| K032054 | RADIONICS NASHOLD BIOPSY NEEDLE - SINGLE USE | Sep 15, 2003 | Substantially Equivalent | RADIONICS, A DIVISION OF TYCO HEALTHCARE GROUP LP |
| K031337 | ACUMEN SURGICAL NAVIGATION SYSTEM | Sep 15, 2003 | Substantially Equivalent | BIOMET, INC. |
| K031770 | CI TKR/UKR | Aug 12, 2003 | Substantially Equivalent | BRAINLAB, AG |
| K031999 | ELEKTA LEKSELL STEREOTACTIC SYSTEM WITH MR POST KIT | Jul 25, 2003 | Substantially Equivalent | ELEKTA INSTRUMENT AB |
| K031980 | MODIFICATION TO LEKSELL STEREOTACTIC SYSTEM | Jul 25, 2003 | Substantially Equivalent | ELEKTA INSTRUMENT AB |
| K024192 | VECTORVISION FLUORO3D | Jun 11, 2003 | Substantially Equivalent | BRAINLAB, AG |
| K022579 | STRYKER NAVIGATION SYSTEM-KNEE MODULE | Jun 02, 2003 | Substantially Equivalent | STRYKER LEIBINGER |
| K030827 | NAVITRACK SYSTEM: TOTAL HIP REPLACEMENT CT-FREE CUP, MODEL 900.204 | May 23, 2003 | Substantially Equivalent | ORTHOSOFT, INC. |
| K031156 | NAVITRACK SYSTEM-FLUOROSPINE, MODEL 900.005 | May 09, 2003 | Substantially Equivalent | ORTHOSOFT, INC. |
| K023424 | IGI-SYSTEM | May 09, 2003 | Substantially Equivalent | DENX ADVANCED DENTAL SYSTEMS |
| K030343 | DIEGO POWERED DISSECTOR HANDPIECE WITH STARLINK IMAGE-GUIDED ADAPTER MOUNTING INTERFACE | May 02, 2003 | Substantially Equivalent | GYRUS ENT L.L.C. |
| K030764 | Z-BOX | Apr 24, 2003 | Substantially Equivalent | Z-KAT, INC. |
| K030552 | IMAGELESS KNEE MODULE FOR THE STEALTHSTATION SYSTEM | Mar 19, 2003 | Substantially Equivalent | MEDTRONIC SURGICAL NAVIGATION TECHNOLOGIES |
| K024201 | NAVIGUS FIDUCIAL MARKER SYSTEM, MODELS FM-1000, FM-2000 | Mar 12, 2003 | Substantially Equivalent | IMAGE-GUIDED NEUROLOGICS, INC. |
| K023949 | NAVIGUS II TRAJECTORY GUIDE WITH VERIFICATION RETICULES | Feb 25, 2003 | Substantially Equivalent | IMAGE-GUIDED NEUROLOGICS, INC. |
| K030106 | STEALTHSTATION SYSTEM ADVANCED CONTOUR REGISTRATION SOFTWARE MODULE | Feb 12, 2003 | Substantially Equivalent | MEDTRONIC SURGICAL NAVIGATION TECHNOLOGIES |
| K022364 | NAVITRACK SYSTEM TOTAL HIP REPLACEMENT,MODEL 900.200 | Feb 04, 2003 | Substantially Equivalent | ORTHOSOFT, INC. |
| K022365 | STRYKER NAVIGATION SYSTEM - HIP MODULE | Jan 22, 2003 | Substantially Equivalent | STRYKER INSTRUMENTS |
| K022126 | CATHETER INTRODUCER FOR THE STEALTHSTATION SYSTEM | Jan 03, 2003 | Substantially Equivalent | MEDTRONIC SURGICAL NAVIGATION TECHNOLOGIES |
| K023975 | VOYAGER LINUX | Dec 20, 2002 | Substantially Equivalent | Z-KAT, INC. |
| K021798 | SMITH & NEPHEW IMAGE GUIDED SURGICAL INSTRUMENTS FOR HIP APPLICATIONS | Dec 09, 2002 | Substantially Equivalent | SMITH & NEPHEW, INC. |
| K021980 | HIP MODULE FOR THE STEALTHSTATION SYSTEM | Nov 19, 2002 | Substantially Equivalent | MEDTRONIC SURGICAL NAVIGATION TECHNOLOGIES |
| K021306 | VECTORVISION CT-FREE KNEE | Oct 25, 2002 | Substantially Equivalent | BRAINLAB AG |
| K021815 | SMITH & NEPHEW IMAGE SURGICAL INSTRUMENTS FOR TRAUMA APPLICATIONS | Oct 17, 2002 | Substantially Equivalent | SMITH & NEPHEW, INC. |
| K022100 | NAVIGUS MANUAL DISPOSABLE MICRODRIVE WITH DIGITAL DISPLAY, MODELS MI-1000 & MI-1010 | Sep 25, 2002 | Substantially Equivalent | IMAGE-GUIDED NEUROLOGICS, INC. |
| K020631 | IPLAN | Sep 09, 2002 | Substantially Equivalent | BRAINLAB AG |
| K021760 | NAVITRACK SYSTEM-OPTICAL TKR CT-LESS, MODEL 900.120 | Aug 27, 2002 | Substantially Equivalent | ORTHOSOFT, INC. |
| K022460 | SMITH & NEPHEW IMAGE GUIDED SURGICAL SYSTEM FOR KNEE APPLICATIONS | Aug 19, 2002 | Substantially Equivalent | SMITH & NEPHEW, INC. |
| K022414 | STEALTHSTATION SYSTEM THREE DIMENSIONAL C-ARM INTERFACE | Aug 14, 2002 | Substantially Equivalent | MEDTRONIC SURGICAL NAVIGATION TECHNOLOGIES |
| K022074 | SPHERZ | Aug 13, 2002 | Substantially Equivalent | I.Z.I. CORP. |
| K013396 | ALPHA DRIVE SYSTEM | Aug 07, 2002 | Substantially Equivalent | ALPHA OMEGA LTD. |
| K021327 | ORTHOPILOT HTO MODULE | Jul 25, 2002 | Substantially Equivalent | AESCULAP, INC. |
| K014256 | KOLIBRI IGS SYSTEMS | Jul 19, 2002 | Substantially Equivalent | BRAINLAB AG |
| K014113 | ENDOMAP | Jun 14, 2002 | Substantially Equivalent | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K020764 | NAVIPRO | Jun 03, 2002 | Substantially Equivalent | KINAMED, INC. |
| K020298 | GALILEO CAS/NAV TKR SYSTEM | May 20, 2002 | Substantially Equivalent | PLUS ORTHOPEDICS |
| K013569 | ORTHOPILOT 2 | Apr 04, 2002 | Substantially Equivalent | AESCULAP, INC. |
| K013428 | MAYFIELD/ACCISS OPERATING ARM SYSTEM AND MAYFIELD/OPTICAL ACCISS SYSTEM | Apr 04, 2002 | Substantially Equivalent | OHIO MEDICAL INSTRUMENT CO., INC. |
| K012448 | VECTORVISION TRAUMA | Mar 14, 2002 | Substantially Equivalent | BRAINLAB AG |
| K020338 | STEALTHSTATION WITH FLUOROMERGE SOFTWARE | Feb 27, 2002 | Substantially Equivalent | MEDTRONIC SURGICAL NAVIGATION TECHNOLOGIES |
| K012938 | SMITH & NEPHEW IMAGE GUIDED SURGICAL INSTRUMENTS FOR KNEE APPLICATIONS | Feb 08, 2002 | Substantially Equivalent | SMITH & NEPHEW, INC. |
| K012937 | KNEE MODULE FOR THE STEALTHSTATION SYSTEM | Jan 25, 2002 | Substantially Equivalent | MEDTRONIC SURGICAL NAVIGATION TECHNOLOGIES |
| K011255 | 3D LINE STEROTACTIC HARDWARE ACCESSORIES | Dec 20, 2001 | Substantially Equivalent | 3D LINE USA, INC. |
| K013861 | MODIFICATION TO LEKSELL SURGIPLAN WITH ATLASPACE | Dec 06, 2001 | Substantially Equivalent | ELEKTA INSTRUMENT AB |
| K012380 | MODIFICATION TO: STRYKER NAVIGATION SYSTEM, STRYKER FLUOROSCOPY SYSTEM,VIRTUAL FLUOROSCOPY | Dec 03, 2001 | Substantially Equivalent | STRYKER LEIBINGER |
| K013257 | HEMI-ARC SURGICAL NAVIGATOR | Oct 30, 2001 | Substantially Equivalent | NUVASIVE, INC. |
| K012719 | NAVIGUS II MR | Oct 22, 2001 | Substantially Equivalent | IMAGE-GUIDED NEUROLOGICS, INC. |
| K012886 | CBYON SYSTEM WITH IMAGE ENHANCED FLUOROSCOPY MODULE | Oct 09, 2001 | Substantially Equivalent | CBYON, INC. |
| K013025 | MODIFICATION TO FLOUROLAB PLUS | Oct 03, 2001 | Substantially Equivalent | Z-KAT, INC. |
| K012366 | NAVIGUS II TRAJECTORY GUIDE | Oct 01, 2001 | Substantially Equivalent | IMAGE-GUIDED NEUROLOGICS, INC. |
| K010602 | VECTORVISION HIP | Sep 12, 2001 | Substantially Equivalent | BRAINLAB, AG |
| K012564 | MODIFICATION TO: VECTORVISION FRAMELESS BIOPSY SYSTEM | Sep 06, 2001 | Substantially Equivalent | BRAINLAB AG |
| K010612 | VECTORVISION KNEE | Sep 06, 2001 | Substantially Equivalent | BRAINLAB, AG |
| K010204 | STRYKER NAVIGATION SYSTEM-KNEE MODULE | Aug 31, 2001 | Substantially Equivalent | STRYKER CORP. |
| K011775 | MICRO TARGETING DRIVE SYSTEM | Aug 30, 2001 | Substantially Equivalent | FHC, INC. |
| K010968 | VECTORVISION CT/FLUORO | Aug 30, 2001 | Substantially Equivalent | BRAINLAB, AG |
| K011992 | FHC MICROTARGETING DRIVE SYSTEM | Aug 14, 2001 | Substantially Equivalent | FHC, INC. |
| K011971 | NAVIGUS TRAJECTORY GUIDE BIOPSY KIT, MODELS BK-7000 AND 8000 | Aug 03, 2001 | Substantially Equivalent | IMAGE-GUIDED NEUROLOGICS, INC. |
| K003589 | VECTORVISION CRANIAL, VECTORVISION SPINAL, VECTORVISION ENT | May 21, 2001 | Substantially Equivalent | BRAINLAB AG |
| K003486 | STEREOTACTIC FRAME BASED SYSTEM | May 17, 2001 | Substantially Equivalent | STRYKER INSTRUMENTS |
| K010542 | SNN SYSTEM INCLUDING THE TOMOGUIDE OPTION | May 08, 2001 | Substantially Equivalent | SURGICAL NAVIGATION SPECIALISTS, INC. |
| K010427 | LORENZ FIDUCAIL SCREW | Mar 15, 2001 | Substantially Equivalent | WALTER LORENZ SURGICAL, INC. |
| K010548 | MODIFICATION TO OPTICAL TRACKING SYSTEM (OTS) | Mar 12, 2001 | Substantially Equivalent | RADIONICS, A DIVISION OF TYCO HEALTHCARE GROUP LP |
| K003699 | MEDIVISION IGS SYSTEM | Feb 27, 2001 | Substantially Equivalent | MEDIVISION (U.S.A.), INC. |
| K003776 | MICROTARGETING DRIVE SYSTEM | Feb 23, 2001 | Substantially Equivalent | FHC, INC. |
| K003347 | ORTHOPILOT | Feb 23, 2001 | Substantially Equivalent | KINAMED, INC. |
| K003268 | Z-TOUCH | Feb 22, 2001 | Substantially Equivalent | BRAINLAB, AG |
| K004027 | STRYKER REMOTE SURGICAL PLANNING SYSTEM | Jan 24, 2001 | Substantially Equivalent | STRYKER INSTRUMENTS |
| K003111 | STRYKER NAVIGATION SYSTEM-SPINE & FLUOROSCOPY MODULES | Jan 04, 2001 | Substantially Equivalent | STRYKER INSTRUMENTS |
| K003201 | STEALTHSTATION TREATMENT GUIDANCE PLATFORM | Dec 12, 2000 | Substantially Equivalent | MEDTRONIC SURGICAL NAVIGATION TECHNOLOGIES |
| K002893 | FLUOROLAB PLUS | Dec 04, 2000 | Substantially Equivalent | Z-KAT, INC. |
| K002732 | STRYKER NAVIGATION SYSTEM - ENT MODULE | Oct 02, 2000 | Substantially Equivalent | STRYKER CORP. |
| K001642 | INSIGHT IMAGE GUIDED SURGICAL SYSTEM | Sep 12, 2000 | Substantially Equivalent | SURGICAL INSIGHTS, INC. |
| K002053 | NAVITRAK SYSTEM-OPTICAL OPTION, MODEL 900.004 | Aug 03, 2000 | Substantially Equivalent | ORTHOSOFT, INC. |
| K001950 | OPTICAL TRACKING SYSTEM (OTS) | Jul 26, 2000 | Substantially Equivalent | RADIONICS, INC. |
| K001801 | STEATHSTATION TREATMENT GUIDANCE PLATFORM | Jun 30, 2000 | Substantially Equivalent | MEDTRONIC SURGICAL NAVIGATION |
| K001284 | STEALTHSTATION SYSTEM GOLDENEYE MICRO-MAGNETIC TRACKING SYSTEM | Jun 12, 2000 | Substantially Equivalent | MEDTRONIC SURGICAL NAVIGATION TECHNOLOGIES |
| K001192 | SELF ADHERING NAVIGUS GUIDE | Jun 07, 2000 | Substantially Equivalent | IMAGE-GUIDED NEUROLOGICS, INC. |
| K001431 | MODIFICATION TO OPTICAL TRACKING SYSTEM (OTS) | May 17, 2000 | Substantially Equivalent | RADIONICS, INC. |
| K001153 | MODIFICATION TO STEATHSTATION TREATMENT GUIDANCE PLATFORM | May 03, 2000 | Substantially Equivalent | MEDTRONIC SURGICAL NAVIGATION |
| K000171 | CBYON SURGICAL OPERATING SYSTEM (SOS) | Mar 13, 2000 | Substantially Equivalent | CBYON, INC. |
| K994421 | SNN STEREOTAXIC PLANNING APPLICATION; SNN STEREOTACTIC APPLICATION | Feb 23, 2000 | Substantially Equivalent | SURGICAL NAVIGATION SPECIALISTS, INC. |
| K992461 | STEALTHSTATION TREATMENT GUIDANCE PLATFORM | Feb 22, 2000 | Substantially Equivalent | SURGICAL NAVIGATION TECHNOLOGIES, INC. |
| K000310 | VOYAGER 6.0 SOFTWARE OPTION | Feb 15, 2000 | Substantially Equivalent | PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. |
| K993239 | STRYKER NAVIGATION SYSTEM - NEURO MODULE, MODEL 6000-XXX-XXX | Jan 18, 2000 | Substantially Equivalent | STRYKER CORP. |
| K992916 | BRAINLAB STEREOTACTIC ARC | Jan 11, 2000 | Substantially Equivalent | BRAINLAB |
| K992927 | STEALTHSTATION TREATMENT GUIDANCE PLATFORM | Dec 29, 1999 | Substantially Equivalent | SURGICAL NAVIGATION TECHNOLOGIES, INC. |
| K993673 | SNN FLUORO NAVIGATION SYSTEM | Dec 21, 1999 | Substantially Equivalent | I.S.G. TECHNOLOGIES, INC. |
| K991706 | VIRTUOSO-STEREOTAXIC PLANNING SOFTWARE | Dec 07, 1999 | Substantially Equivalent | STRYKER CORP. |
| K993501 | 3D1 MICROPOSITIONING HEADSTAGE | Nov 22, 1999 | Substantially Equivalent | SCIENTIFIC TOOLS, INC. |
| K990683 | AXON MP-1 MICROPOSITIONER | Nov 03, 1999 | Substantially Equivalent | AXON INSTRUMENTS, INC. |
| K992843 | THE MAYFIELD / ACCISS SYSTEM WITH WINDOWS NT FOR CRANIAL SURGERY, THE MAYFIELD / OPTICAL ACCISS SYSTEM WITH WINDOWS NT F | Nov 02, 1999 | Substantially Equivalent | OHIO MEDICAL INSTRUMENT CO., INC. |
| K991256 | VIEWPOINT ENT/ORTHOPEDIC OPTION | Oct 08, 1999 | Substantially Equivalent | PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. |
| K992882 | LEKSELL IMAGE GUIDANCE SURGICAL SYSTEM, VIEW SCOPE, SURGISCOPE,ELEKTA INSIGHT | Sep 24, 1999 | Substantially Equivalent | ELEKTA INSTRUMENT AB |
| K983410 | @ TARGET | Sep 17, 1999 | Substantially Equivalent | BRAINLAB, AG |
| K992721 | COSMAN ROBERT WELLS FUNCTIONAL PROBE MICRODRIVE | Sep 10, 1999 | Substantially Equivalent | RADIONICS, INC. |
| K992457 | SNN SYSTEM WITH OLIVIER DOUBLE CHUCK SUPPORT ARM OPTION | Aug 27, 1999 | Substantially Equivalent | SURGICAL NAVIGATION SPECIALISTS, INC. |
| K992304 | NAVIGUS TRAJECTORY GUIDE, MODEL TG-XXXX | Aug 27, 1999 | Substantially Equivalent | IMAGE-GUIDED NEUROLOGICS, INC. |
| K990907 | REMOTE INTRODUCER, MODEL PI-1000 | Aug 12, 1999 | Substantially Equivalent | IMAGE-GUIDED NEUROLOGICS, INC. |
| K991636 | ELEKTA STEREOTACTIC GUIDE | Jul 20, 1999 | Substantially Equivalent | ELEKTA INSTRUMENT AB |
| K991267 | SPINE APPLICATIONS FOR THE MAYFIELD/ACCISS OPERATING ARM AND OPTICAL ACCISS SYSTEMS MODULE, MAYFIELD/ACCISS SPINE RING A | Jul 12, 1999 | Substantially Equivalent | OHIO MEDICAL INSTRUMENT CO., INC. |
| K983764 | VIEWPOINT TOOLS- STERRAD | Jul 08, 1999 | Substantially Equivalent | PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. |
| K991081 | FRAMELESS NEUROMATE | Jun 25, 1999 | Substantially Equivalent | INTEGRATED SURGICAL SYSTEMS, INC. |
| K984298 | Z KAT FLUROTACTIC GUIDANCE SYSTEM MKI | Jun 23, 1999 | Substantially Equivalent | Z-KAT, INC. |
| K983831 | VECTORVISION2 | May 19, 1999 | Substantially Equivalent | BRAINLAB, AG |
| K990632 | OPTICAL TRACKING SYSTEM (OTS) | Apr 29, 1999 | Substantially Equivalent | RADIONICS, INC. |
| K990214 | FLUORONAV MODULE FOR THE STEALTHSTATION SYSTEM | Apr 22, 1999 | Substantially Equivalent | SURGICAL NAVIGATION TECHNOLOGIES, INC. |
| K990868 | VIEWPOINT PASSIVE TOOL OPTION | Mar 30, 1999 | Substantially Equivalent | PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. |
| K990860 | VIEWPOINT MICROSCOPE OPTION | Mar 30, 1999 | Substantially Equivalent | PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. |
| K990326 | OPTICAL TRACKING SYSTEM MICROSCOPE MODULE II, MODEL OTS MMII | Mar 04, 1999 | Substantially Equivalent | RADIONICS SOFTWARE APPLICATIONS, INC. |
| K983539 | TRAJECTORY GUIDE, MODEL # TGX-XXX | Feb 12, 1999 | Substantially Equivalent | IMAGE-GUIDED NEUROLOGICS, INC. |
| K981480 | PHILIPS EASYGUIDE | Jan 28, 1999 | Substantially Equivalent | PHILIPS MEDICAL SYSTEMS, INC. |
| K983670 | STEALTHSTATION SYSTEM | Jan 14, 1999 | Substantially Equivalent | SURGICAL NAVIGATION TECHNOLOGIES, INC. |
| K982570 | SNN SCOUT | Jan 13, 1999 | Substantially Equivalent | I.S.G. TECHNOLOGIES, INC. |
| K984245 | NON-INVASIVE DYNAMIC REFERENCE FRAME (DRF) FOR OPTICAL TRACKING SYSTEM, MODEL OTS | Dec 18, 1998 | Substantially Equivalent | RADIONICS, INC. |
| K983397 | STEALTHSTATION TREATMENT GUIDANCE PLAFFORM | Dec 04, 1998 | Substantially Equivalent | SURGICAL NAVIGATION TECHNOLOGIES, INC. |
| K981768 | STEALTHSTATION TREATMENT GUIDANCE PLATFORM | Nov 23, 1998 | Substantially Equivalent | SURGICAL NAVIGATION TECHNOLOGIES, INC. |
| K983669 | OPTICAL TRACKING SYSTEM WITH SURFACE MATCHING MODULE, MODEL OTS | Nov 18, 1998 | Substantially Equivalent | RADIONICS, INC. |
| K983603 | REFLECTIVE SPHERE STANDARD PROBE AND REFLECTIVE SPHERE DYNAMIC REFERENCE FRAME | Nov 10, 1998 | Substantially Equivalent | RADIONICS, INC. |
| K981508 | VECTORVISION SPINE MODULE | Oct 29, 1998 | Substantially Equivalent | BRAINLAB, AG |
| K980820 | PHILIPS EASYGUIDE | Oct 13, 1998 | Substantially Equivalent | PHILIPS MEDICAL SYSTEMS, INC. |
| K982244 | MAYFIELD ACCISS OPTICAL SYSTEM | Sep 23, 1998 | Substantially Equivalent | OHIO MEDICAL INSTRUMENT CO., INC. |
| K961903 | MAGELLAN | Aug 24, 1998 | Substantially Equivalent | BIOSENSE, LTD. |
| K981809 | CAROLINE GUIDE | Aug 14, 1998 | Substantially Equivalent | SURGICAL SOLUTIONS, INC. |
| K981686 | STEALTHSTATION SYSTEM DIGITIZER CHANGE | Aug 07, 1998 | Substantially Equivalent | SURGICAL NAVIGATION TECHNOLOGIES, INC. |
| K981684 | STEALTHSTATION TREATMENT GUIDANCE PLATFORM | Aug 06, 1998 | Substantially Equivalent | SURGICAL NAVIGATION TECHNOLOGIES, INC. |
| K982364 | WIRELESS STANDARD PROBE, DYNAMIC REFERENCE FRAME (DRF) | Aug 05, 1998 | Substantially Equivalent | RADIONICS, INC. |
| K981315 | NAVITRACK | Jul 09, 1998 | Substantially Equivalent | ORTHOSOFT, INC. |
| K981213 | UNIVERSAL INSTRUMENT REGISTRATION (UIR) MICROSCOPE MODULE I | Jul 01, 1998 | Substantially Equivalent | RADIONICS, INC. |
| K980584 | ATLASPLAN | May 18, 1998 | Substantially Equivalent | RADIONICS, INC. |
| K974602 | OPTICAL TRACKING SYSTEM (OTS) | Apr 21, 1998 | Substantially Equivalent | RADIONICS SOFTWARE APPLICATIONS, INC. |
| K973684 | LEKSELL VIEWSCOPE, LEKSELL SURGISCOPE, LEKSELL FREEHAND | Mar 31, 1998 | Substantially Equivalent | ELEKTA INSTRUMENT AB |
| K972324 | LEKSELL STEREOTACTIC SYSTEM | Mar 02, 1998 | Substantially Equivalent | ELEKTA INSTRUMENT AB |
| K974187 | STEALTHSTATION SYSTEM | Jan 21, 1998 | Substantially Equivalent | SURGICAL NAVIGATION TECHNOLOGIES, INC. |
| K974161 | STEALTHSTATION SYSTEM | Nov 21, 1997 | Substantially Equivalent | SURGICAL NAVIGATION TECHNOLOGIES, INC. |
| K973277 | CAROLINE GUIDE/DELIA LOCALIZER | Nov 17, 1997 | Substantially Equivalent | SURGICAL SOLUTIONS, INC. |
| K972398 | STEALTHSTATION PASSIVE INSTRUMENT OPTION | Sep 16, 1997 | Substantially Equivalent | SURGICAL NAVIGATION TECHNOLOGIES, INC. |
| K964229 | REGULUS NAVIGATOR | Aug 19, 1997 | Substantially Equivalent | COMPASS INTL., INC. |
| K971675 | SNT STEREOTACTIC LOCALIZATION SYSTEM | Jul 14, 1997 | Substantially Equivalent | SURGICAL NAVIGATION TECHNOLOGIES, INC. |
| K971247 | SNT DISPOSABLE BIOPSY NEEDLE | Jun 16, 1997 | Substantially Equivalent | SURGICAL NAVIGATION TECHNOLOGIES, INC. |
| K970865 | ISG FAMILY OF VIEWING WANDS | Jun 04, 1997 | Substantially Equivalent | I.S.G. TECHNOLOGIES, INC. |
| K964801 | OPTICAL TRACKING SYSTEM (OTS) | Jun 02, 1997 | Substantially Equivalent | RADIONICS SOFTWARE APPLICATIONS, INC. |
| K962939 | VECTORVISION | May 22, 1997 | Substantially Equivalent | BRAINLAB, INC. |
| K970604 | VIEWPOINT - 3.0 SOFTWARE | May 19, 1997 | Substantially Equivalent | PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. |
| K963256 | NEUROMATE STEREOTACTIC SYSTEM | May 09, 1997 | Substantially Equivalent | INTEGRATED SURGICAL SYSTEMS, S.A. |
| K965139 | SURGICAL MICROSCOPE NAVIGATOR (SMN) SYSTEM/SURGICAL TOOL NAVIGATOR (STN) SYSTEM | Apr 23, 1997 | Substantially Equivalent | CARL ZEISS, INC. |
| K963221 | OPTICAL DIGITIZER OPTION FOR VIEW POINT | Jan 10, 1997 | Substantially Equivalent | PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. |
| K961834 | PHILIPS EASYGUIDE NEURO | Nov 08, 1996 | Substantially Equivalent | PHILIPS MEDICAL SYSTEMS, INC. |
| K963173 | STEALTHSTATION SYSTEM | Oct 25, 1996 | Substantially Equivalent | SURGICAL NAVIGATION TECHNOLOGIES, INC. |
| K961844 | OPERATING ARM SYSTEM (OAS) [WITH CT AND MR IMAGES] | Oct 23, 1996 | Substantially Equivalent | RADIONICS SOFTWARE APPLICATIONS, INC. |
| K954789 | BRAINLAB HEADPINS | Aug 12, 1996 | Substantially Equivalent | BRAINLAB, AG |
| K961858 | COSGROVE DEPTH ELECTRODE KIT(CDEK) | Aug 07, 1996 | Substantially Equivalent | RADIONICS, INC. |
| K961639 | LEKSELL IMAGE GUIDANCE SURGICAL SYSTEM (LIGS) | Jul 26, 1996 | Substantially Equivalent | ELEKTA INSTRUMENT AB |
| K960714 | ISG VIEWING WAND | May 29, 1996 | Substantially Equivalent | I.S.G. TECHNOLOGIES, INC. |
| K961120 | MARKER SYSTEM FOR STEREOTAXIC NAVIGATION | May 10, 1996 | Substantially Equivalent | HOWMEDICA LEIBINGER, INC. |
| K955397 | MAYFIELD-ACCISS WORKSTATION | Apr 30, 1996 | Substantially Equivalent | NOMOS CORP. |
| K953568 | CODMAN FIDUCIAL MARKER SYSTEM | Feb 29, 1996 | Substantially Equivalent | Codman & Shurtleff, Inc. |
| K952390 | BRAINLAB STEROTATIC HEADRING | Feb 02, 1996 | Substantially Equivalent | BRAINLAB MED. COMPUTERSYSTEME GMBH |
| K954276 | STEALTHSTATION | Jan 24, 1996 | Substantially Equivalent | SURGICAL NAVIGATION TECHNOLOGIES, INC. |
| K944463 | CRW-1 SYSTEM | Oct 26, 1995 | Substantially Equivalent | RADIONICS SOFTWARE APPLICATIONS, INC. |
| K935456 | REGULUS MEASUREMENT UNIT | Oct 13, 1995 | Substantially Equivalent | COMPASS INTL., INC. |
| K946033 | LEIBINGER STEREOPLAN PLUS STEROTACTIC TREATMENT PLAN ING SOFTWARE PACKAGE | Sep 01, 1995 | Substantially Equivalent | LEIBINGER GMBH |
| K946252 | STEREOPLAN | Mar 14, 1995 | Substantially Equivalent | RADIONICS SOFTWARE APPLICATIONS, INC. |
| K943468 | LEKSELL SURGIPLAN | Jan 20, 1995 | Substantially Equivalent | ELEKTA INSTRUMENTS, INC. |
| K936019 | NOMOS STEREOTACTIC BIOPSY INSTRUMENTS | Mar 22, 1994 | Substantially Equivalent | NOMOS CORP. |
| K931991 | GNOMOS STEREOTACTIC SYSTEM W/ NONINVASIVE FIXATION | Aug 20, 1993 | Substantially Equivalent | NOMOS CORP. |
| K924348 | AD-TECH'S BRAIN BIOPSY NEEDLE FOR STEREOTAXIC | Nov 23, 1992 | Substantially Equivalent | AD-TECH MEDICAL INSTRUMENT CORP. |
| K915791 | CORITAXIC MULTI-MODAL STEREOTAXI WORKSTATION | Jul 10, 1992 | Substantially Equivalent | CORITECHS, INC. |
| K915819 | BRAINSCAN WORKSTATION | May 11, 1992 | Substantially Equivalent | BRAINLAB MEDIZINISCHE COMPUTERSYSTEME GMBH |
| K901883 | STEREOTACTIC ONE MEDICAL APPLICATION SOFTWARE | Mar 07, 1991 | Substantially Equivalent | STEREOTACTIC IMAGE SYSTEMS, INC. |
| K901670 | GNOMOS STEREOTACTIC DEVICE | Jul 03, 1990 | Substantially Equivalent | MEDICAL EQUIPMENT DEVELOPMENT CO., INC. |
| K900200 | COOK STEREOTAXIC GUIDE | May 31, 1990 | Substantially Equivalent | COOK, INC. |
| K894387 | WESTCO MADAYAG PAB NEEDLE | Nov 07, 1989 | Substantially Equivalent | WESTERN MEDICAL, LTD. |
| K894263 | CASS SYSTEM | Sep 01, 1989 | Substantially Equivalent | MEDICAL INSTRUMENTATION & DIAGNOSTICS CORP.(MIDCO) |
| K881132 | LAITINEN'S TRIGEMINUS STEREOGUIDE | Aug 09, 1988 | Substantially Equivalent | SANDSTROM TRADE & TECHNOLOGY, INC. |
| K881131 | THE LAITINEN STEREOTACTIC SYSTEM | Aug 01, 1988 | Substantially Equivalent | SANDSTROM TRADE & TECHNOLOGY, INC. |
| K874693 | OBT STEREOTACTIC SYSTEM | Mar 11, 1988 | Substantially Equivalent | TIPAL INSTRUMENTS LTD. |
| K874833 | ARC ADAPTER ASSEMBLY | Mar 03, 1988 | Substantially Equivalent | MEDICAL EQUIPMENT DEVELOPMENT CO., INC. |
| K872877 | TARGET PROGRAM & EPSON HX-20 COMPUTER | Feb 12, 1988 | Substantially Equivalent | WALTER LORENZ SURGICAL, INC. |
| K871046 | COMPASS STEREOTACTIC POSITIONING SYSTEM | May 08, 1987 | Substantially Equivalent | STEREOTACTIC MEDICAL SYSTEMS, INC. |
| K861629 | KOMAI CT-STEREOTACTIC APPARATUS AND ACCESSORIES | Aug 12, 1986 | Substantially Equivalent | DOWNS SURGICAL LTD. |
| K862220 | COMPASS CT STEREOTACTIC ADAPTATION SYSTEM | Jun 18, 1986 | Substantially Equivalent | STEREOTACTIC MEDICAL SYSTEMS, INC. |
| K854475 | GHAJAR INTRAVENTRICULAR CATHETER GUIDE | Feb 20, 1986 | Substantially Equivalent | SPARTA INSTRUMENT CORP. |
| K852662 | GOUDA FRAME FOR STEREOTACTIC NEUROSURGERY | Aug 21, 1985 | Substantially Equivalent | NEUROSURGICAL DEVICES, INC. |
| K852477 | KELLY-GROERSS-KALL CT STEROTACTIC ADAPTATION SYS | Jul 30, 1985 | Substantially Equivalent | Mayo Clinic |
| K851973 | DIASONICS, BERGER STEREOTACTIC NEOROBIOPSY | Jul 26, 1985 | Substantially Equivalent | DIASONICS, INC. |
| K851659 | SKULL MOUNTED STEREOTACTIC SURGICAL DEVICE | Jul 01, 1985 | Substantially Equivalent | MEDCO PRODUCTS, CO., INC. |
| K833484 | COMPUTED TOMOGRAPHY ORIENTED ROTARY ARC | Dec 29, 1983 | Substantially Equivalent | A. PATIL, M.D. |
| K830999 | DAP II BIOPSY GUIDE | Jul 12, 1983 | Substantially Equivalent | RAPID MACHINE & TOOL CORP. |
| K831329 | PMT VAXIOM STEREOTACTIC SYS #FX001 | Jun 15, 1983 | Substantially Equivalent | PROGRESS MANKIND TECHNOLOGY |
| K823424 | MENISCECTOMY TRAY #9715 | Mar 17, 1983 | Substantially Equivalent | CONCEPT, INC. |
| K823675 | FRONING GUIDANCE SYSTEM #TX-8200 | Jan 05, 1983 | Substantially Equivalent | TODAY'S MACHINING & DESIGN, INC. |
| K812744 | LEVY BIOTAC #LX001 BIOPSY PROBE HOLDER | Dec 03, 1981 | Substantially Equivalent | PROGRESS MANKIND TECHNOLOGY |
| K811452 | BROWN-ROBERTS-WELLS STEREOTAXIC SYTEM | Jun 02, 1981 | Substantially Equivalent | TRENT WELLS, INC. |
| K790502 | DYONICS STEROTOXIC POSITIONER | Apr 05, 1979 | Substantially Equivalent | DYONICS, INC. |
FEI Numbers
This FDA classification entry is associated with 246 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 246 registration numbers. Click on an entry to view related FDA registrations.