The following data is part of a premarket notification filed by Medacta International S.a. with the FDA for Glenoid Reconstruction System.
| Device ID | K213459 |
| 510k Number | K213459 |
| Device Name: | Glenoid Reconstruction System |
| Classification | Shoulder Prosthesis, Reverse Configuration |
| 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 | PHX |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-10-27 |
| Decision Date | 2022-11-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630345710529 | K213459 | 000 |
| 07630345710307 | K213459 | 000 |
| 07630345710314 | K213459 | 000 |
| 07630345710321 | K213459 | 000 |
| 07630345710338 | K213459 | 000 |
| 07630345710345 | K213459 | 000 |
| 07630345710352 | K213459 | 000 |
| 07630345710369 | K213459 | 000 |
| 07630345710376 | K213459 | 000 |
| 07630345710383 | K213459 | 000 |
| 07630345710390 | K213459 | 000 |
| 07630345710406 | K213459 | 000 |
| 07630345710499 | K213459 | 000 |
| 07630345710505 | K213459 | 000 |
| 07630345710512 | K213459 | 000 |
| 07630345710291 | K213459 | 000 |