MectaLIF Anterior Extension— 510(k) K221545

Substantially Equivalent

Medacta International S.A.

FDA 510(k) clearance K221545 for MectaLIF Anterior Extension, Substantially Equivalent on 2022-10-24. Applicant: Medacta International S.A..

Clearance details

Applicant: Medacta International S.A.
Product code: Code OVD
Advisory panel: Orthopedic
Date received: 2022-05-27
Decision date: 2022-10-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Castel San Pietro (Ch), CH

Download summary PDF View on FDA.gov ↗

Adverse events under product code OVD

product code OVD

Death: 5
Injury: 495
Total: 500

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.