The following data is part of a premarket notification filed by Medacta International Sa with the FDA for Humeral Eccentric Reverse Metaphysis.
| Device ID | K210207 |
| 510k Number | K210207 |
| Device Name: | Humeral Eccentric Reverse Metaphysis |
| Classification | Shoulder Prosthesis, Reverse Configuration |
| Applicant | Medacta International SA Strada Regina Castel San Pietro, CH Ch-6874 |
| Contact | Stefano Baj |
| Correspondent | Chris Lussier Medacta USA 3973 Delp Street Memphis, TN 83118 |
| Product Code | PHX |
| Subsequent Product Code | KWS |
| Subsequent Product Code | MBF |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-01-26 |
| Decision Date | 2021-03-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630345716781 | K210207 | 000 |