K231787

Substantially Equivalent

ecoFIX®

Applicant: Science & Bio Materials (S.B.M.) Sas
Product code: MAI
Advisory panel: Orthopedic
Date received: 2023-06-20
Decision date: 2023-07-26
Decision: Substantially Equivalent
Clearance type: Special
Location: Lourdes, FR

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.