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 |