The following data is part of a premarket notification filed by Medacta International Sa with the FDA for Fairfix Adjustable Button System.
Device ID | K203259 |
510k Number | K203259 |
Device Name: | FairFix Adjustable Button System |
Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
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 | MBI |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-11-05 |
Decision Date | 2021-03-26 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
07630345703934 | K203259 | 000 |
07630345703927 | K203259 | 000 |