K203493

Substantially Equivalent

MectaLock Extension

Applicant: Medacta International S.A.
Product code: MAI
Advisory panel: Orthopedic
Date received: 2020-11-27
Decision date: 2021-02-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Castel San Pietro (Ch), CH

Adverse events under product code MAI

product code MAI

Injury: 1,948
Malfunction: 8,580
Total: 10,528

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.