The following data is part of a premarket notification filed by Medacta International, Sa with the FDA for Medacta Shoulder System.
| Device ID | K192967 |
| 510k Number | K192967 |
| Device Name: | Medacta Shoulder System |
| Classification | Shoulder Prosthesis, Reverse Configuration |
| Applicant | Medacta International, SA Strada Regina Castel San Pietro, 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 | KWT |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-10-23 |
| Decision Date | 2020-03-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630040733960 | K192967 | 000 |
| 07630040734066 | K192967 | 000 |
| 07630040734059 | K192967 | 000 |
| 07630040734042 | K192967 | 000 |
| 07630040734035 | K192967 | 000 |
| 07630040734028 | K192967 | 000 |
| 07630040734011 | K192967 | 000 |
| 07630040734004 | K192967 | 000 |
| 07630040733991 | K192967 | 000 |
| 07630040733984 | K192967 | 000 |
| 07630040734073 | K192967 | 000 |
| 07630040734080 | K192967 | 000 |
| 07630040733953 | K192967 | 000 |
| 07630040733946 | K192967 | 000 |
| 07630040733939 | K192967 | 000 |
| 07630040733922 | K192967 | 000 |
| 07630040734134 | K192967 | 000 |
| 07630040734127 | K192967 | 000 |
| 07630040734110 | K192967 | 000 |
| 07630040734103 | K192967 | 000 |
| 07630040734097 | K192967 | 000 |
| 07630040733977 | K192967 | 000 |