The following data is part of a premarket notification filed by Medacta International Sa with the FDA for Gmk Sphere.
| Device ID | K162035 |
| 510k Number | K162035 |
| Device Name: | GMK Sphere |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | Medacta International SA Strada Regina Castel San Pietro, CH Ch-6874 |
| Contact | Stefano Baj |
| Correspondent | Elizabeth Rose Mapi USA, Inc 2343 Alexandria Drive Suite 100 Lexington, KY 40504 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-07-22 |
| Decision Date | 2017-03-06 |
| Summary: | summary |