The following data is part of a premarket notification filed by Medacta International Sa with the FDA for M.u.s.t. Mini Posterior Cervical Screws System.
Device ID | K203149 |
510k Number | K203149 |
Device Name: | M.U.S.T. MINI Posterior Cervical Screws System |
Classification | Posterior Cervical 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 | NKG |
CFR Regulation Number | 888.3075 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-10-22 |
Decision Date | 2020-11-16 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
07630971299542 | K203149 | 000 |
07630345705877 | K203149 | 000 |
07630345705884 | K203149 | 000 |
07630345705891 | K203149 | 000 |
07630345705907 | K203149 | 000 |
07630345705914 | K203149 | 000 |
07630345705921 | K203149 | 000 |
07630345705938 | K203149 | 000 |
07630345705945 | K203149 | 000 |
07630345705952 | K203149 | 000 |
07630971299559 | K203149 | 000 |
07630971299566 | K203149 | 000 |
07630971299573 | K203149 | 000 |
07630971299580 | K203149 | 000 |
07630971299597 | K203149 | 000 |
07630971299528 | K203149 | 000 |
07630971299535 | K203149 | 000 |
07630345705860 | K203149 | 000 |