FDA Product Code
FDA Product Code HAW — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Neurology
- 21 CFR Citation
- 882.4560
510(k) Clearances — 425 records · page 3 of 5
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K042721 | KOLIBRI SPINE | Brainlab AG | 2005-04-19 | Traditional | PDF ↗ |
| K050377 | NBD HEAD SCREW | New Business Development, LLC | 2005-04-07 | Traditional | PDF ↗ |
| K043223 | DEPUY CAS KNEE INSTRUMENTATION | DePuy Orthopaedics, Inc. | 2005-03-04 | Traditional | PDF ↗ |
| K042513 | VECTORVISION OSTEOTOMY | Brainlab AG | 2005-02-10 | Traditional | PDF ↗ |
| K043091 | NAVIGUS NEXDRIVE, MODEL MI-3000 | Image-Guided Neurologics, Inc. | 2005-02-07 | Traditional | PDF ↗ |
| K043536 | NAVITRACK SYSTEM - S&N IMAGE FREE KNEE | Orthosoft, Inc. | 2005-01-14 | Special | PDF ↗ |
| K042512 | VECTORVISION ACL | Brainlab AG | 2005-01-13 | Traditional | PDF ↗ |
| K043088 | MEDTRONIC SNT STEALTHSTATION AXIEM IMAGELESS KNEE MODULE | Medtronic Surgical Navigation Technologies | 2005-01-05 | Traditional | PDF ↗ |
| K041477 | PATHFINDER | Armstrong Healthcare Limited | 2004-12-09 | Traditional | PDF ↗ |
| K041703 | IPLAN! | Brainlab AG | 2004-10-22 | Traditional | PDF ↗ |
| K042391 | KOLIBRI IMAGE GUIDED SURGERY SYSTEM | Brainlab AG | 2004-10-19 | Traditional | PDF ↗ |
| K041899 | VECTORVISION UNI-KNEE | Brainlab AG | 2004-10-06 | Special | PDF ↗ |
| K040334 | NAVIGUS PASSIVE PROBE, MODEL NP-1000 | Image-Guided Neurologics, Inc. | 2004-10-04 | Traditional | PDF ↗ |
| K041330 | IPLAN! FLOW | Brainlab AG | 2004-09-22 | Traditional | PDF ↗ |
| K033341 | SMITH & NEPHEW IMAGE GUIDED SURGICAL INSTRUMENTS FOR HIP APPLICATIONS | Smith & Nephew, Inc. | 2004-09-10 | Special | PDF ↗ |
| K040368 | VECTORVISION HIP 3.0 | Brainlab AG | 2004-08-23 | Traditional | PDF ↗ |
| K040979 | ELEKTA MICRODRIVE, MODEL 916716 | Elekta Instrument AB | 2004-07-23 | Traditional | PDF ↗ |
| K031454 | ACUMEN SURGICAL NAVIGATION SYSTEM | Biomet, Inc. | 2004-07-08 | Traditional | PDF ↗ |
| K041369 | NAVITRACK SYSTEM - S&N IMAGE FREE HIP, MODEL PRO-03017 | Orthosoft, Inc. | 2004-06-22 | Special | PDF ↗ |
| K040834 | NAVIGUS PASSIVE PROBE (BL), MODEL NP-2000 | Image-Guided Neurologics, Inc. | 2004-06-03 | Traditional | PDF ↗ |
| K033668 | NAVIPRO KNEE SOFTWARE MODULE | Kinamed, Inc. | 2004-03-11 | Traditional | PDF ↗ |
| K033619 | NAVIGUS UNIBODY FIDUCIAL MARKER SYSTEM, MODEL FM-4000 | Image-Guided Neurologics, Inc. | 2004-03-02 | Traditional | PDF ↗ |
| K033223 | ZIMMER ORTHO GUIDANCE SYSTEMS- HIP INSTRUMENTS | Zimmer, Inc. | 2004-02-18 | Traditional | PDF ↗ |
| K023651 | VECTORVISION CRANIAL/ENT | Brainlab AG | 2004-02-17 | Traditional | PDF ↗ |
| K033011 | ZIMMER ORTHO GUIDANCE SYSTEMS- KNEE INSTRUMENTS | Zimmer, Inc. | 2004-02-12 | Traditional | PDF ↗ |
| K033340 | LEKSELL SURGIPLAN WITH IMAGEMERGE | Elekta Instrument AB | 2004-02-12 | Special | PDF ↗ |
| K033621 | NDI PASSIVE SPHERES | Northern Digital, Inc. | 2004-01-27 | Traditional | PDF ↗ |
| K033413 | SPINEASSIST DEVICE | Mazor Surgical Technologies , Ltd. | 2004-01-07 | Traditional | PDF ↗ |
| K032917 | NAVITRACK SYSTEM - TOTAL HIP REPLACEMENT CT-FREE | Orthosoft, Inc. | 2003-10-21 | Special | PDF ↗ |
| K031732 | EBI ACUMEN SURGICAL NAVIGATION SYSTEM | Ebi, L.P. | 2003-10-15 | Traditional | PDF ↗ |
| K031337 | ACUMEN SURGICAL NAVIGATION SYSTEM | Biomet, Inc. | 2003-09-15 | Traditional | PDF ↗ |
| K032054 | RADIONICS NASHOLD BIOPSY NEEDLE - SINGLE USE | Radionics, A Division of Tyco Healthcare Group LP | 2003-09-15 | Traditional | PDF ↗ |
| K031770 | CI TKR/UKR | Brainlab AG | 2003-08-12 | Traditional | PDF ↗ |
| K031999 | ELEKTA LEKSELL STEREOTACTIC SYSTEM WITH MR POST KIT | Elekta Instrument AB | 2003-07-25 | Special | PDF ↗ |
| K031980 | MODIFICATION TO LEKSELL STEREOTACTIC SYSTEM | Elekta Instrument AB | 2003-07-25 | Special | PDF ↗ |
| K024192 | VECTORVISION FLUORO3D | Brainlab AG | 2003-06-11 | Traditional | PDF ↗ |
| K022579 | STRYKER NAVIGATION SYSTEM-KNEE MODULE | Stryker Leibinger | 2003-06-02 | Traditional | PDF ↗ |
| K030827 | NAVITRACK SYSTEM: TOTAL HIP REPLACEMENT CT-FREE CUP, MODEL 900.204 | Orthosoft, Inc. | 2003-05-23 | Traditional | PDF ↗ |
| K023424 | IGI-SYSTEM | Denx Advanced Dental Systems | 2003-05-09 | Traditional | PDF ↗ |
| K031156 | NAVITRACK SYSTEM-FLUOROSPINE, MODEL 900.005 | Orthosoft, Inc. | 2003-05-09 | Special | PDF ↗ |
| K030343 | DIEGO POWERED DISSECTOR HANDPIECE WITH STARLINK IMAGE-GUIDED ADAPTER MOUNTING INTERFACE | Gyrus Ent LLC | 2003-05-02 | Traditional | PDF ↗ |
| K030764 | Z-BOX | Z-Kat, Inc. | 2003-04-24 | Special | PDF ↗ |
| K030552 | IMAGELESS KNEE MODULE FOR THE STEALTHSTATION SYSTEM | Medtronic Surgical Navigation Technologies | 2003-03-19 | Special | PDF ↗ |
| K024201 | NAVIGUS FIDUCIAL MARKER SYSTEM, MODELS FM-1000, FM-2000 | Image-Guided Neurologics, Inc. | 2003-03-12 | Traditional | PDF ↗ |
| K023949 | NAVIGUS II TRAJECTORY GUIDE WITH VERIFICATION RETICULES | Image-Guided Neurologics, Inc. | 2003-02-25 | Traditional | PDF ↗ |
| K030106 | STEALTHSTATION SYSTEM ADVANCED CONTOUR REGISTRATION SOFTWARE MODULE | Medtronic Surgical Navigation Technologies | 2003-02-12 | Special | PDF ↗ |
| K022364 | NAVITRACK SYSTEM TOTAL HIP REPLACEMENT,MODEL 900.200 | Orthosoft, Inc. | 2003-02-04 | Traditional | PDF ↗ |
| K022365 | STRYKER NAVIGATION SYSTEM - HIP MODULE | Stryker Instruments | 2003-01-22 | Traditional | PDF ↗ |
| K022126 | CATHETER INTRODUCER FOR THE STEALTHSTATION SYSTEM | Medtronic Surgical Navigation Technologies | 2003-01-03 | Traditional | PDF ↗ |
| K023975 | VOYAGER LINUX | Z-Kat, Inc. | 2002-12-20 | Special | PDF ↗ |
| K021798 | SMITH & NEPHEW IMAGE GUIDED SURGICAL INSTRUMENTS FOR HIP APPLICATIONS | Smith & Nephew, Inc. | 2002-12-09 | Abbreviated | PDF ↗ |
| K021980 | HIP MODULE FOR THE STEALTHSTATION SYSTEM | Medtronic Surgical Navigation Technologies | 2002-11-19 | Traditional | PDF ↗ |
| K021306 | VECTORVISION CT-FREE KNEE | Brainlab AG | 2002-10-25 | Traditional | PDF ↗ |
| K021815 | SMITH & NEPHEW IMAGE SURGICAL INSTRUMENTS FOR TRAUMA APPLICATIONS | Smith & Nephew, Inc. | 2002-10-17 | Abbreviated | PDF ↗ |
| K022100 | NAVIGUS MANUAL DISPOSABLE MICRODRIVE WITH DIGITAL DISPLAY, MODELS MI-1000 & MI-1010 | Image-Guided Neurologics, Inc. | 2002-09-25 | Traditional | PDF ↗ |
| K020631 | IPLAN | Brainlab AG | 2002-09-09 | Traditional | PDF ↗ |
| K021760 | NAVITRACK SYSTEM-OPTICAL TKR CT-LESS, MODEL 900.120 | Orthosoft, Inc. | 2002-08-27 | Traditional | PDF ↗ |
| K022460 | SMITH & NEPHEW IMAGE GUIDED SURGICAL SYSTEM FOR KNEE APPLICATIONS | Smith & Nephew, Inc. | 2002-08-19 | Special | PDF ↗ |
| K022414 | STEALTHSTATION SYSTEM THREE DIMENSIONAL C-ARM INTERFACE | Medtronic Surgical Navigation Technologies | 2002-08-14 | Special | PDF ↗ |
| K022074 | SPHERZ | I.Z.I. Corp. | 2002-08-13 | Traditional | PDF ↗ |
| K013396 | ALPHA DRIVE SYSTEM | Alpha Omega , Ltd. | 2002-08-07 | Special | PDF ↗ |
| K021327 | ORTHOPILOT HTO MODULE | Aesculap, Inc. | 2002-07-25 | Traditional | PDF ↗ |
| K014256 | KOLIBRI IGS SYSTEMS | Brainlab AG | 2002-07-19 | Traditional | PDF ↗ |
| K014113 | ENDOMAP | Siemens Medical Solutions USA, Inc. | 2002-06-14 | Traditional | PDF ↗ |
| K020764 | NAVIPRO | Kinamed, Inc. | 2002-06-03 | Traditional | PDF ↗ |
| K020298 | GALILEO CAS/NAV TKR SYSTEM | Plus Orthopedics | 2002-05-20 | Traditional | PDF ↗ |
| K013569 | ORTHOPILOT 2 | Aesculap, Inc. | 2002-04-04 | Traditional | PDF ↗ |
| K013428 | MAYFIELD/ACCISS OPERATING ARM SYSTEM AND MAYFIELD/OPTICAL ACCISS SYSTEM | Ohio Medical Instrument Co., Inc. | 2002-04-04 | Traditional | PDF ↗ |
| K012448 | VECTORVISION TRAUMA | Brainlab AG | 2002-03-14 | Traditional | PDF ↗ |
| K020338 | STEALTHSTATION WITH FLUOROMERGE SOFTWARE | Medtronic Surgical Navigation Technologies | 2002-02-27 | Special | PDF ↗ |
| K012938 | SMITH & NEPHEW IMAGE GUIDED SURGICAL INSTRUMENTS FOR KNEE APPLICATIONS | Smith & Nephew, Inc. | 2002-02-08 | Abbreviated | PDF ↗ |
| K012937 | KNEE MODULE FOR THE STEALTHSTATION SYSTEM | Medtronic Surgical Navigation Technologies | 2002-01-25 | Traditional | PDF ↗ |
| K011255 | 3D LINE STEROTACTIC HARDWARE ACCESSORIES | 3D Line USA, Inc. | 2001-12-20 | Traditional | PDF ↗ |
| K013861 | MODIFICATION TO LEKSELL SURGIPLAN WITH ATLASPACE | Elekta Instrument AB | 2001-12-06 | Special | PDF ↗ |
| K012380 | MODIFICATION TO: STRYKER NAVIGATION SYSTEM, STRYKER FLUOROSCOPY SYSTEM,VIRTUAL FLUOROSCOPY | Stryker Leibinger | 2001-12-03 | Traditional | PDF ↗ |
| K013257 | HEMI-ARC SURGICAL NAVIGATOR | Nuvasive, Inc. | 2001-10-30 | Special | PDF ↗ |
| K012719 | NAVIGUS II MR | Image-Guided Neurologics, Inc. | 2001-10-22 | Traditional | PDF ↗ |
| K012886 | CBYON SYSTEM WITH IMAGE ENHANCED FLUOROSCOPY MODULE | Cbyon, Inc. | 2001-10-09 | Special | PDF ↗ |
| K013025 | MODIFICATION TO FLOUROLAB PLUS | Z-Kat, Inc. | 2001-10-03 | Special | PDF ↗ |
| K012366 | NAVIGUS II TRAJECTORY GUIDE | Image-Guided Neurologics, Inc. | 2001-10-01 | Traditional | PDF ↗ |
| K010602 | VECTORVISION HIP | Brainlab AG | 2001-09-12 | Traditional | PDF ↗ |
| K010612 | VECTORVISION KNEE | Brainlab AG | 2001-09-06 | Traditional | PDF ↗ |
| K012564 | MODIFICATION TO: VECTORVISION FRAMELESS BIOPSY SYSTEM | Brainlab AG | 2001-09-06 | Special | PDF ↗ |
| K010204 | STRYKER NAVIGATION SYSTEM-KNEE MODULE | Stryker Corp. | 2001-08-31 | Traditional | PDF ↗ |
| K010968 | VECTORVISION CT/FLUORO | Brainlab AG | 2001-08-30 | Traditional | PDF ↗ |
| K011775 | MICRO TARGETING DRIVE SYSTEM | FHC, Inc. | 2001-08-30 | Traditional | PDF ↗ |
| K011992 | FHC MICROTARGETING DRIVE SYSTEM | FHC, Inc. | 2001-08-14 | Special | PDF ↗ |
| K011971 | NAVIGUS TRAJECTORY GUIDE BIOPSY KIT, MODELS BK-7000 AND 8000 | Image-Guided Neurologics, Inc. | 2001-08-03 | Traditional | PDF ↗ |
| K003589 | VECTORVISION CRANIAL, VECTORVISION SPINAL, VECTORVISION ENT | Brainlab AG | 2001-05-21 | Traditional | PDF ↗ |
| K003486 | STEREOTACTIC FRAME BASED SYSTEM | Stryker Instruments | 2001-05-17 | Traditional | PDF ↗ |
| K010542 | SNN SYSTEM INCLUDING THE TOMOGUIDE OPTION | Surgical Navigation Specialists, Inc. | 2001-05-08 | Traditional | PDF ↗ |
| K010427 | LORENZ FIDUCAIL SCREW | Walter Lorenz Surgical, Inc. | 2001-03-15 | Traditional | PDF ↗ |
| K010548 | MODIFICATION TO OPTICAL TRACKING SYSTEM (OTS) | Radionics, A Division of Tyco Healthcare Group LP | 2001-03-12 | Special | PDF ↗ |
| K003699 | MEDIVISION IGS SYSTEM | Medivision (U.S.A.), Inc. | 2001-02-27 | Traditional | PDF ↗ |
| K003776 | MICROTARGETING DRIVE SYSTEM | FHC, Inc. | 2001-02-23 | Traditional | PDF ↗ |
| K003347 | ORTHOPILOT | Kinamed, Inc. | 2001-02-23 | Traditional | PDF ↗ |
| K003268 | Z-TOUCH | Brainlab AG | 2001-02-22 | Traditional | PDF ↗ |
| K004027 | STRYKER REMOTE SURGICAL PLANNING SYSTEM | Stryker Instruments | 2001-01-24 | Special | PDF ↗ |
| K003111 | STRYKER NAVIGATION SYSTEM-SPINE & FLUOROSCOPY MODULES | Stryker Instruments | 2001-01-04 | Traditional | PDF ↗ |
| K003201 | STEALTHSTATION TREATMENT GUIDANCE PLATFORM | Medtronic Surgical Navigation Technologies | 2000-12-12 | Traditional | PDF ↗ |
Product code HAW · Class II · Neurology. Data: openFDA.