The following data is part of a premarket notification filed by Medacta International S.a. with the FDA for Gmk 3d Metal Tibial Tray.
| Device ID | K221850 |
| 510k Number | K221850 |
| Device Name: | GMK 3D Metal Tibial Tray |
| Classification | Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, 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 | MBH |
| CFR Regulation Number | 888.3565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-06-27 |
| Decision Date | 2022-08-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630345710925 | K221850 | 000 |
| 07630345710789 | K221850 | 000 |
| 07630345710772 | K221850 | 000 |
| 07630345717740 | K221850 | 000 |
| 07630345717566 | K221850 | 000 |
| 07630345717559 | K221850 | 000 |
| 07630345717542 | K221850 | 000 |
| 07630345717535 | K221850 | 000 |
| 07630345717528 | K221850 | 000 |
| 07630345717511 | K221850 | 000 |
| 07630345717504 | K221850 | 000 |
| 07630345710949 | K221850 | 000 |
| 07630345710796 | K221850 | 000 |
| 07630345710802 | K221850 | 000 |
| 07630345710918 | K221850 | 000 |
| 07630345710901 | K221850 | 000 |
| 07630345710895 | K221850 | 000 |
| 07630345710888 | K221850 | 000 |
| 07630345710871 | K221850 | 000 |
| 07630345710864 | K221850 | 000 |
| 07630345710857 | K221850 | 000 |
| 07630345710840 | K221850 | 000 |
| 07630345710833 | K221850 | 000 |
| 07630345710826 | K221850 | 000 |
| 07630345710819 | K221850 | 000 |
| 07630345710932 | K221850 | 000 |