The following data is part of a premarket notification filed by Medacta Inernational Sa with the FDA for Lateralized Glenosphere.
| Device ID | K193175 |
| 510k Number | K193175 |
| Device Name: | Lateralized Glenosphere |
| Classification | Shoulder Prosthesis, Reverse Configuration |
| Applicant | Medacta Inernational SA 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 |
| Subsequent Product Code | HSD |
| Subsequent Product Code | MBF |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-11-18 |
| Decision Date | 2020-08-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630040728119 | K193175 | 000 |
| 07630040728102 | K193175 | 000 |
| 07630040728096 | K193175 | 000 |
| 07630040728089 | K193175 | 000 |
| 07630040728072 | K193175 | 000 |
| 07630040728065 | K193175 | 000 |
| 07630040728058 | K193175 | 000 |
| 07630040728041 | K193175 | 000 |
| 07630040728034 | K193175 | 000 |