The following data is part of a premarket notification filed by Medacta International Sa with the FDA for Myshoulder Placement Guides.
| Device ID | K190738 |
| 510k Number | K190738 |
| Device Name: | MyShoulder Placement Guides |
| 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 38118 |
| Product Code | PHX |
| Subsequent Product Code | HSD |
| 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 | 2019-03-22 |
| Decision Date | 2019-12-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630030861673 | K190738 | 000 |
| 07630030861666 | K190738 | 000 |
| 07630030861659 | K190738 | 000 |
| 07630030861642 | K190738 | 000 |
| 07630030861192 | K190738 | 000 |
| 07630030861185 | K190738 | 000 |
| 07630030861178 | K190738 | 000 |
| 07630030861161 | K190738 | 000 |