The following data is part of a premarket notification filed by Medacta International Sa with the FDA for Fairfix Adjustable Button System.
Device ID | K222169 |
510k Number | K222169 |
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 | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2022-07-21 |
Decision Date | 2022-08-16 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
07630345797032 | K222169 | 000 |
07630345797025 | K222169 | 000 |
07630345797018 | K222169 | 000 |