The following data is part of a premarket notification filed by Medacta International, Sa with the FDA for Imns Medacta Navigation System,33.221000us.
| Device ID | K100314 |
| 510k Number | K100314 |
| Device Name: | IMNS MEDACTA NAVIGATION SYSTEM,33.221000US |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | MEDACTA INTERNATIONAL, SA 4725 CALLE QUETZAL SUITE B Camarillo, CA 93012 |
| Contact | Heather Neely |
| Correspondent | Heather Neely MEDACTA INTERNATIONAL, SA 4725 CALLE QUETZAL SUITE B Camarillo, CA 93012 |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-02-04 |
| Decision Date | 2010-03-31 |
| Summary: | summary |