The following data is part of a premarket notification filed by Medacta International Sa with the FDA for Shoulder System - Tinbn Coating.
| Device ID | K203755 |
| 510k Number | K203755 |
| Device Name: | Shoulder System - TiNbN Coating |
| 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 | 2020-12-23 |
| Decision Date | 2021-03-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630345709059 | K203755 | 000 |
| 07630345708908 | K203755 | 000 |
| 07630345708892 | K203755 | 000 |
| 07630345708885 | K203755 | 000 |
| 07630345708878 | K203755 | 000 |
| 07630345708861 | K203755 | 000 |
| 07630345708854 | K203755 | 000 |
| 07630345708847 | K203755 | 000 |
| 07630345708830 | K203755 | 000 |
| 07630345708823 | K203755 | 000 |
| 07630345708816 | K203755 | 000 |
| 07630345708809 | K203755 | 000 |
| 07630345708793 | K203755 | 000 |
| 07630345708915 | K203755 | 000 |
| 07630345708922 | K203755 | 000 |
| 07630345709042 | K203755 | 000 |
| 07630345709035 | K203755 | 000 |
| 07630345709028 | K203755 | 000 |
| 07630345709011 | K203755 | 000 |
| 07630345709004 | K203755 | 000 |
| 07630345708991 | K203755 | 000 |
| 07630345708984 | K203755 | 000 |
| 07630345708977 | K203755 | 000 |
| 07630345708960 | K203755 | 000 |
| 07630345708953 | K203755 | 000 |
| 07630345708946 | K203755 | 000 |
| 07630345708939 | K203755 | 000 |
| 07630345708786 | K203755 | 000 |