MyPAO SA guides— 510(k) K242603

Substantially Equivalent

Medacta International S.A.

FDA 510(k) clearance K242603 for MyPAO SA guides, Substantially Equivalent on 2025-11-19. Applicant: Medacta International S.A..

Clearance details

Applicant: Medacta International S.A.
Product code: Code PBF
Advisory panel: Orthopedic
Date received: 2024-08-30
Decision date: 2025-11-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Castel San Pietro, CH

Download summary PDF View on FDA.gov ↗

Adverse events under product code PBF

product code PBF

Injury: 180
Total: 180

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.