The following data is part of a premarket notification filed by Medacta International Sa with the FDA for Gmk Hinge, Gmk Revision.
| Device ID | K172347 |
| 510k Number | K172347 |
| Device Name: | GMK Hinge, GMK Revision |
| Classification | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer |
| Applicant | Medacta International SA Strada Regina Castel San Pietro, CH Ch-6874 |
| Contact | Stefano Baj |
| Correspondent | Roshana Ahmed Mapi USA, Inc. 2343 Alexandria Drive Suite 100 Lexington, KY 40504 |
| Product Code | KRO |
| CFR Regulation Number | 888.3510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-08-03 |
| Decision Date | 2017-11-01 |
| Summary: | summary |