The following data is part of a premarket notification filed by Medacta International with the FDA for Versafitcup Cc Trio.
| Device ID | K103352 |
| 510k Number | K103352 |
| Device Name: | VERSAFITCUP CC TRIO |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | MEDACTA INTERNATIONAL 13721 VIA TRES VISTA San Diego, CA 92129 |
| Contact | Natalie J Kennel |
| Correspondent | Natalie J Kennel MEDACTA INTERNATIONAL 13721 VIA TRES VISTA San Diego, CA 92129 |
| Product Code | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-11-16 |
| Decision Date | 2011-02-11 |
| Summary: | summary |