FairFix AM Adjustable Button FairFix PSP Adjustable Button— 510(k) K221389

Substantially Equivalent

Medacta International S.A.

FDA 510(k) clearance K221389 for FairFix AM Adjustable Button FairFix PSP Adjustable Button, Substantially Equivalent on 2022-06-08. Applicant: Medacta International S.A..

Clearance details

Applicant: Medacta International S.A.
Product code: Code MBI
Advisory panel: Orthopedic
Date received: 2022-05-13
Decision date: 2022-06-08
Decision: Substantially Equivalent
Clearance type: Special
Location: Castel San Pietro (Ch), CH

Download summary PDF View on FDA.gov ↗

Adverse events under product code MBI

product code MBI

Injury: 3,163
Malfunction: 13,006
Other: 2
Total: 16,171

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.