The following data is part of a premarket notification filed by Medacta International Sa with the FDA for Medacta Shoulder System: Threaded Glenoid Baseplate.
| Device ID | K171058 |
| 510k Number | K171058 |
| Device Name: | Medacta Shoulder System: Threaded Glenoid Baseplate |
| Classification | Shoulder Prosthesis, Reverse Configuration |
| 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 | PHX |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-04-10 |
| Decision Date | 2017-12-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630040715492 | K171058 | 000 |
| 07630040715485 | K171058 | 000 |
| 07630040715478 | K171058 | 000 |
| 07630040708098 | K171058 | 000 |