The following data is part of a premarket notification filed by Medacta International Sa with the FDA for M.u.s.t. Pedicle Screw System.
| Device ID | K193365 |
| 510k Number | K193365 |
| Device Name: | M.U.S.T. Pedicle Screw System |
| Classification | Thoracolumbosacral Pedicle Screw System |
| 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 | NKB |
| Subsequent Product Code | KWP |
| Subsequent Product Code | KWQ |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-04 |
| Decision Date | 2020-01-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630040728805 | K193365 | 000 |
| 07630040728799 | K193365 | 000 |
| 07630040728782 | K193365 | 000 |
| 07630040728775 | K193365 | 000 |