The following data is part of a premarket notification filed by Medacta International Sa with the FDA for Gmk Uni.
| Device ID | K161741 |
| 510k Number | K161741 |
| Device Name: | GMK UNI |
| Classification | Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer |
| Applicant | MEDACTA INTERNATIONAL SA STRADA REGINA Castel San Pietro, CH Ch-6874 |
| Contact | Stefano Baj |
| Correspondent | Stefano Baj MEDACTA INTERNATIONAL, SA STRADA REGINA 6874 Castel San Pietro, CH |
| Product Code | HSX |
| CFR Regulation Number | 888.3520 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-06-24 |
| Decision Date | 2017-04-14 |
| Summary: | summary |