The following data is part of a premarket notification filed by Medacta International S.a. with the FDA for M.u.s.t. Mini Posterior Cervical Screws System Extension.
Device ID | K220570 |
510k Number | K220570 |
Device Name: | M.U.S.T. MINI Posterior Cervical Screws System Extension |
Classification | Posterior Cervical Screw System |
Applicant | Medacta International S.A. Strada Regina Castel San Pietro, CH CH-6874 |
Contact | Stefano Baj |
Correspondent | Chris Lussier Medacta USA 3973 Delp Street Memphis, TN 38118 |
Product Code | NKG |
CFR Regulation Number | 888.3075 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2022-02-28 |
Decision Date | 2022-04-26 |