GENTAFIX® (1, 3, 3MV)— 510(k) K242216

Substantially Equivalent

Teknimed Sas

FDA 510(k) clearance K242216 for GENTAFIX® (1, 3, 3MV), Substantially Equivalent on 2024-12-18. Applicant: Teknimed Sas.

Clearance details

Applicant: Teknimed Sas
Product code: Code MBB
Advisory panel: Orthopedic
Date received: 2024-07-29
Decision date: 2024-12-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: L'Union, FR

Download summary PDF View on FDA.gov ↗

Adverse events under product code MBB

product code MBB

Death: 27
Injury: 1,412
Malfunction: 551
Total: 1,990

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.