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 | K162061 |
| 510k Number | K162061 |
| 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 | Elizabeth Wheeler MAPI USA, INC 2343 ALEXANDRIA DR, SUITE 100 Lexington, KY 40504 |
| Product Code | NKB |
| Subsequent Product Code | KWP |
| Subsequent Product Code | KWQ |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-07-26 |
| Decision Date | 2016-10-21 |
| Summary: | summary |