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 2 of 5
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K132755 | NEUROMATE FRAMELESS GEN II | Renishaw Mayfield Sarl | 2014-04-29 | Traditional | PDF ↗ |
| K132611 | MICROTABLE SYSTEM | Fred Haer Company, Inc. | 2014-03-06 | Traditional | PDF ↗ |
| K131214 | CRANIAL MAP NEURO | Stryker Corporate | 2013-10-18 | Traditional | PDF ↗ |
| K130874 | STRYKER NAV3I PLATFORM | Stryker Corporate | 2013-09-27 | Traditional | PDF ↗ |
| K130608 | QUADCUT | Medtronic Navigation, Inc. | 2013-08-07 | Traditional | PDF ↗ |
| K122211 | SYNTHES NAVIGABLE PEDICLE PREPARATION INSTRUMENTS | Synthes Spine | 2012-12-17 | Traditional | PDF ↗ |
| K122096 | KARL STORZ NAVIGATIONPANEL UNIT (NPU) SYSTEM | KARL STORZ Endoscopy-America, Inc. | 2012-09-27 | Traditional | PDF ↗ |
| K121950 | MICROTARGETING XL STAR DRIVE SYSTEM | FHC, Inc. | 2012-07-26 | Special | PDF ↗ |
| K120812 | RENAISSANCE | Mazor Robotics , Ltd. | 2012-07-12 | Traditional | PDF ↗ |
| K110644 | PRAEZIS PLUS | Tatramed Spol. S.R.O. | 2012-05-24 | Traditional | PDF ↗ |
| K112094 | BRAIN BIOPSY NEEDLE | Ad-Tech Medical Instrument Corp | 2012-04-24 | Traditional | PDF ↗ |
| K111558 | SURGICASE GUIDE | Materialise NV | 2012-03-27 | Traditional | PDF ↗ |
| K112469 | GENERAL PRUPOSE LOCALIZERS AND ADAPTERS-NEW ACCESSORIES FOR SONOWAND SYSTEM | Sonowand AS | 2012-03-23 | Traditional | PDF ↗ |
| K113228 | RENAISSANCE SYSTEM | Mazor Robotics , Ltd. | 2011-12-01 | Special | PDF ↗ |
| K101627 | IPLAN | Brainlab AG | 2011-06-03 | Traditional | PDF ↗ |
| K110911 | RENAISSANCE SYSTEM | Mazor Robotics , Ltd. | 2011-04-28 | Special | PDF ↗ |
| K103192 | NAVIGATION MARKER, REFLECTIVE MARKER SPHERES | Ilumark GmbH | 2011-02-07 | Traditional | PDF ↗ |
| K101791 | ROSA SURGICAL DEVICE | Medtech S.A.S | 2010-09-23 | Traditional | PDF ↗ |
| K102130 | TENZING SYSTEM | Mazor Surgical Technologies , Ltd. | 2010-08-26 | Special | PDF ↗ |
| K100038 | DISPOSABLE REFLECTIVE MARKER SPHERES | Brainlab AG | 2010-07-14 | Traditional | PDF ↗ |
| K092467 | VECTORVISION CRANIAL, VECTORVISION ENT, KOLIBRI CRANIAL, KOLIBRI ENT, CRANIAL ESSENTIAL, CRANIAL UNLIMITED | Brainlab AG | 2010-05-06 | Special | PDF ↗ |
| K100314 | IMNS MEDACTA NAVIGATION SYSTEM,33.221000US | Medacta International S.A. | 2010-03-31 | Special | PDF ↗ |
| K092192 | WAYPOINT STEREOTACTIC SYSTEM | FHC, Inc. | 2010-02-12 | Traditional | PDF ↗ |
| K092239 | ROSA SURGICAL DEVICE, MODEL ROSA 1.1 | Medtech S.A | 2009-11-17 | Traditional | PDF ↗ |
| K090190 | WIN-NEUS STEREOTACTIC SURGERY TREATMENT PLANNING SYSTEM | Nuclemed S.A. | 2009-10-09 | Traditional | PDF ↗ |
| K083597 | SONOWAND INVITE | Sonowand AS | 2009-09-25 | Traditional | PDF ↗ |
| K092562 | MICROTARGETING STAR DRIVE SYSTEM, COMPONENTS | FHC, Inc. | 2009-09-18 | Special | PDF ↗ |
| K090240 | MONTERIS MEDICAL UFO | Monteris Medical, | 2009-08-06 | Traditional | PDF ↗ |
| K082060 | CRANIAL IMAGE GUIDED SURGERY SYSTEM | Brainlab AG | 2009-05-08 | Traditional | PDF ↗ |
| K080355 | LEKSELL STEREOTACTIC SYSTEM WITH REUSABLE FIXATION SCREWS | Elekta Instrument AB | 2009-05-01 | Traditional | PDF ↗ |
| K083565 | PIGALILEO TOTAL HIP REPLACEMENT (THR) SOFTWARE APPLICATION V3.0 | Smith & Nephew, Inc. | 2009-02-20 | Special | PDF ↗ |
| K081867 | MAKO SURGICAL TACTILE GUIDANCE SYSTEM VERSION 2.0 | Mako Surgical Corp. | 2008-11-25 | Traditional | PDF ↗ |
| K082267 | PIGALILEO CAS, VERSION 4.0 AND TKR BASE, VERSION 2.1 | Smith & Nephew, Inc. | 2008-10-29 | Special | PDF ↗ |
| K073615 | BRAINLAB KNEE ESSENTIAL, BRAINLAB KNEE UNLIMITED CI KNEE, CI KNEE UNLIMITED | Brainlab AG | 2008-09-05 | Traditional | PDF ↗ |
| K081232 | TOTAL KNEE SURGETICS NAVIGATION SYSTEM WITH PRAXITELES | Praxim | 2008-08-06 | Traditional | PDF ↗ |
| K080875 | PIGALILEO 4TH GENERATION SYSTEM | Smith & Nephew, Inc. | 2008-07-18 | Abbreviated | PDF ↗ |
| K080450 | STRYKER POWER TOOL NAVIGATOR ATTACHMENT | Stryker Corp. | 2008-07-17 | Traditional | PDF ↗ |
| K080678 | UNI-KNEE 2.0 | Brainlab AG | 2008-06-06 | Traditional | PDF ↗ |
| K080547 | ORTHOPILOT NEXT GENERATION, MODEL FS101-FS106 | Aesculap Implant System, Inc. | 2008-05-23 | Special | PDF ↗ |
| K073467 | SPINEASSIST SYSTEM | Mazor Surgical Technologies , Ltd. | 2008-05-23 | Traditional | PDF ↗ |
| K080250 | LEKSELL SURGIPLAN, MODEL 1006947 | Elekta Instrument AB | 2008-05-13 | Special | PDF ↗ |
| K072899 | ORTHOPILOT 2 TOTAL HIP ARTHROPLASTY (THA) VERSION 3.0 | Aesculap Implant Systems, Inc. | 2008-02-06 | Special | PDF ↗ |
| K072806 | MAKO SURGICAL TACTILE GUIDANCE SYSTEM (TGS) | Mako Surgical Corp. | 2008-01-24 | Traditional | PDF ↗ |
| K072271 | STRYKER NAVIGATION SYSTEM INFINITUS HIP RESURFACING MODULE | Stryker Corp. | 2007-12-18 | Traditional | PDF ↗ |
| K072267 | TOTAL HIP SURGETICS NAVIGATION SYSTEM | Praxim S.A | 2007-12-10 | Traditional | PDF ↗ |
| K072716 | VECTOR VISION HIP | Brainlab AG | 2007-10-12 | Special | PDF ↗ |
| K072573 | VECTORVISION HIP AND HIP SR | Brainlab AG | 2007-10-11 | Special | PDF ↗ |
| K070556 | BRAINSUITE NET | Brainlab AG | 2007-09-25 | Traditional | PDF ↗ |
| K071929 | NAVITRACK SYSTEM- PARTIAL HIP RESURFACING UNIVERSAL | Orthosoft, Inc. | 2007-09-19 | Traditional | PDF ↗ |
| K063607 | SPINEASSIST SYSTEM | Mazor Surgical Technologies , Ltd. | 2007-08-23 | Traditional | PDF ↗ |
| K070731 | PIGALILEO TOTAL HIP REPLACEMENT (THR) SYSTEM | Plus Orthopedics AG | 2007-07-31 | Traditional | PDF ↗ |
| K071714 | NAVITRACK SYSTEM - OS UNICONDYLAR KNEE UNIVERSAL, MODEL# PRO-06003 | Orthosoft, Inc. | 2007-07-20 | Special | PDF ↗ |
| K071334 | DEPUY CAS HEMI ASR HIP INSTRUMENTS | DePuy Orthopaedics, Inc. | 2007-07-02 | Traditional | PDF ↗ |
| K071135 | DEPUY CI HIP INSTRUMENTATION | DePuy Orthopaedics, Inc. | 2007-05-23 | Special | PDF ↗ |
| K070106 | VV FLUORO 3D | Brainlab AG | 2007-04-23 | Traditional | PDF ↗ |
| K061479 | ARGOS | 3D Line Medical Systems S.R.L. | 2007-04-05 | Traditional | PDF ↗ |
| K063408 | CTLOGICS NAVIGATIONS SYSTEMS | Praxim Medivision, SA | 2007-02-28 | Traditional | PDF ↗ |
| K062358 | MODIFICATION TO VECTORVISION TRAUMA | Brainlab AG | 2007-01-17 | Special | PDF ↗ |
| K062640 | STRYKER NAVIGATION SYSTEM - CRANIAL MODULE, MODEL 6000-650-000 | Stryker Instruments | 2006-12-14 | Traditional | PDF ↗ |
| K063028 | VECTORVISION HIP SR | Brainlab AG | 2006-12-12 | Traditional | PDF ↗ |
| K062228 | ZIMMER HIP COMPUTER ASSISTED SOLUTIONS ELECTROMAGNETIC AND IMAGELESS INSTRUMENTATION | Zimmer, Inc. | 2006-11-08 | Traditional | PDF ↗ |
| K061362 | PIGALILEO TOTAL KNEE REPLACEMENT (TKR) SYSTEM | Plus Orthopedics AG | 2006-10-06 | Traditional | PDF ↗ |
| K062086 | NAVIVISION | Brainlab AG | 2006-09-20 | Traditional | PDF ↗ |
| K061224 | LAPDOC I | Robodent GmbH | 2006-09-05 | Traditional | PDF ↗ |
| K061248 | AXIEM IMAGELESS HIP MODULE FOR THE STEALTHSTATION SYSTEM | Medtronic Navigation, Inc. | 2006-08-31 | Traditional | PDF ↗ |
| K062146 | UNI KNEE SURGETICS NAVIGATION SYSTEM | Praxim S.A | 2006-08-21 | Special | PDF ↗ |
| K060727 | VECTORVISION HIP | Brainlab AG | 2006-08-21 | Special | PDF ↗ |
| K053348 | STRYKER ORTHOPAEDICS RFID INSTRUMENTATION | Howmedica Osteonics Corp. | 2006-08-04 | Traditional | PDF ↗ |
| K060556 | BRIGIT SURGICAL DEVICE | Zimmer, Inc. | 2006-07-31 | Traditional | PDF ↗ |
| K060808 | BRAINPRO, BRAINPRO ACCESS | PAJUNK GmbH Medizintechnologie | 2006-07-25 | Traditional | PDF ↗ |
| K053159 | VECTORVISION SPINE | Brainlab AG | 2006-06-06 | Traditional | PDF ↗ |
| K060336 | NAVITRACK SYSTEM-OS KNEE UNIVERSAL, MODEL PRO-05002 | Orthosoft, Inc. | 2006-04-28 | Special | PDF ↗ |
| K053542 | SURGETICS ORTHO OSTEOLOGICS NAVIGATION SYSTEM | Praxim S.A | 2006-04-10 | Traditional | PDF ↗ |
| K060282 | TOTAL KNEE SURGETICS NAVIGATION SYSTEM | Praxim S.A | 2006-04-10 | Special | PDF ↗ |
| K053164 | IPLAN FLOW | Brainlab AG | 2006-03-23 | Traditional | PDF ↗ |
| K060121 | BIOMET PRE-CALIBRATED COMPUTER AIDED SURGERY NAVIGATION INSTRUMENTS FOR HIP APPLICATIONS | Biomet Manufacturing Corp | 2006-03-21 | Traditional | PDF ↗ |
| K060468 | VECTORVISION HIP | Brainlab AG | 2006-03-20 | Special | PDF ↗ |
| K052623 | IMAGELESS HIP MODULE FOR THE STEALTHSTATION SYSTEM | Medtronic Navigation, Inc. | 2006-03-02 | Special | PDF ↗ |
| K052966 | CI KNEE, CI MI TKR | Brainlab AG | 2006-02-13 | Traditional | PDF ↗ |
| K053127 | IPLAN | Brainlab AG | 2006-02-09 | Traditional | PDF ↗ |
| K052425 | ZIMMER COMPUTER ASSISTED SOLUTIONS-ELECTROMAGNETIC AND IMAGELESS KNEE INSTRUMENTATION | Zimmer, Inc. | 2005-12-28 | Traditional | PDF ↗ |
| K052840 | IGI-SYSTEM | Denx Advanced Dental Systems | 2005-12-16 | Traditional | PDF ↗ |
| K051734 | GE HEALTHCARE INSTA TRAK 3500PLUS/ FLUORO TRAK 9800 PLUS SYSTEM WITH AXCESS BONE PIN, MODEL PART # 1006955 | Ge Healthcare Technologies | 2005-11-23 | Traditional | PDF ↗ |
| K052851 | VOYAGER LINUX WITH TACTILE GUIDANCE SYSTEM (TGS) | Mako Surgical Corp. | 2005-11-18 | Special | PDF ↗ |
| K052213 | NAVIGATION SW HIP 3.1 ON CI | Brainlab AG | 2005-11-02 | Special | PDF ↗ |
| K052178 | DEPUY CAS HIP INSTRUMENTATION | DePuy Orthopaedics, Inc. | 2005-10-21 | Traditional | PDF ↗ |
| K051676 | SPINEASSIST DEVICE WITH ADDITIONAL ACCESSORIES | Mazor Surgical Technologies , Ltd. | 2005-09-08 | Traditional | PDF ↗ |
| K050651 | MEDTRONIC ORTHOPAEDIC TRAUMA APPLICATION | Medtronic Navigation, Inc. | 2005-07-27 | Traditional | PDF ↗ |
| K051746 | ELEKTA ESARTE FRAME SYSTEM | Elekta Instrument AB | 2005-07-25 | Special | PDF ↗ |
| K051724 | ACUMEN IMAGE GUIDED SURGICAL SYSTEM | Ebi, L.P. | 2005-07-19 | Traditional | PDF ↗ |
| K051029 | STELTHSTATION WIRELESS SURGEON MOUSE | Medtronic Surgical Navigation | 2005-06-08 | Special | PDF ↗ |
| K031196 | SURGETICS ORTHO KNEELOGICS NAVIGATION SYSTEM | Praxim | 2005-06-07 | Traditional | PDF ↗ |
| K050438 | STEALTHSTATION SYSTEM UPDATE | Medtronic Surgical Navigation Technologies | 2005-06-02 | Special | PDF ↗ |
| K041897 | MAYFIELD ACCISS II IMAGE GUIDED SURGERY SYSTEM, MODEL 2002-01 | Schaerer Mayfield USA, Inc. | 2005-06-01 | Traditional | PDF ↗ |
| K050897 | NAVIPRO SHOULDER SOFTWARE MODULE | Kinamed, Inc. | 2005-05-24 | Traditional | PDF ↗ |
| K042543 | IPLAN! DIGITAL TEMPLATING | Brainlab AG | 2005-05-17 | Traditional | PDF ↗ |
| K050973 | MODIFICATION TO: VOYAGER LINUX | Mako Surgical Corp. | 2005-05-17 | Special | PDF ↗ |
| K050752 | AESCULAP ORTHOPILOT 2 THA V 2.0 | Aesculap, Inc. | 2005-04-27 | Special | PDF ↗ |
| K050772 | NAVIGUS REUSABLE PASSIVE PROBE, MODEL SP-2000 | Image-Guided Neurologics, Inc. | 2005-04-21 | Traditional | PDF ↗ |
| K050615 | STRYKER NAVIGATION SYSTEM - CT-BASED HIP MODULE, MODEL 6007-621-000 | Stryker Instruments | 2005-04-21 | Special | PDF ↗ |
Product code HAW · Class II · Neurology. Data: openFDA.