Mpact Constrained Liner— 510(k) K241461

Substantially Equivalent

Medacta International S.A.

FDA 510(k) clearance K241461 for Mpact Constrained Liner, Substantially Equivalent on 2025-07-31. Applicant: Medacta International S.A..

Clearance details

Applicant: Medacta International S.A.
Product code: Code KWZ
Advisory panel: Orthopedic
Date received: 2024-05-23
Decision date: 2025-07-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Castel San Pietro, CH

Download summary PDF View on FDA.gov ↗

Adverse events under product code KWZ

product code KWZ

Injury: 993
Total: 993

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.