The following data is part of a premarket notification filed by Medacta International S.a. with the FDA for Gmk Sphere Revision.
| Device ID | K211664 |
| 510k Number | K211664 |
| Device Name: | GMK Sphere Revision |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | Medacta International S.A. Strada Regina Castel San Pietro, CH Ch-6874 |
| Contact | Stefano Baj |
| Correspondent | Chris Lussier Medacta USA 3973 Delp Street Memphis, TN 38118 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-01 |
| Decision Date | 2021-07-29 |