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 |