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 |