M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System— 510(k) K203671

Substantially Equivalent

Medacta International S.A.

FDA 510(k) clearance K203671 for M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System, Substantially Equivalent on 2021-01-13. Applicant: Medacta International S.A..

Clearance details

Applicant: Medacta International S.A.
Product code: Code OUR
Advisory panel: Orthopedic
Date received: 2020-12-16
Decision date: 2021-01-13
Decision: Substantially Equivalent
Clearance type: Special
Location: Castel San Pietro (Ch), CH

Download summary PDF View on FDA.gov ↗

Adverse events under product code OUR

product code OUR

Death: 3
Injury: 347
Total: 350

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.