The following data is part of a premarket notification filed by Medacta International, Sa with the FDA for Imns Medacta Navigation System.
| Device ID | K083872 |
| 510k Number | K083872 |
| Device Name: | IMNS MEDACTA NAVIGATION SYSTEM |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | MEDACTA INTERNATIONAL, SA 13721 VIA TRES VISTA San Diego, CA 92129 |
| Contact | Natlie J Kennel |
| Correspondent | Casey Conry UNDERWRITERS LABORATORIES, INC. 1285 WALT WHITMAN RD. Melville, NY 11747 |
| Product Code | OLO |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2008-12-29 |
| Decision Date | 2009-01-15 |
| Summary: | summary |