The following data is part of a premarket notification filed by Medacta International S.a. with the FDA for Fairfix Am Adjustable Button Fairfix Psp Adjustable Button.
| Device ID | K221389 |
| 510k Number | K221389 |
| Device Name: | FairFix AM Adjustable Button FairFix PSP Adjustable Button |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | Medacta International S.A. Strada Regina Castel San Pietro, CH CH-6874 |
| Contact | Stefano Baj |
| Correspondent | Christopher 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 | 2022-05-13 |
| Decision Date | 2022-06-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630345778703 | K221389 | 000 |
| 07630345778697 | K221389 | 000 |