Refobacin Bone Cement R (110034355)— 510(k) K254107

Substantially Equivalent

Biomet France

FDA 510(k) clearance K254107 for Refobacin Bone Cement R (110034355), Substantially Equivalent on 2026-04-15. Applicant: Biomet France.

Clearance details

Applicant: Biomet France
Product code: Code LOD
Advisory panel: Orthopedic
Date received: 2025-12-19
Decision date: 2026-04-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Valence, FR

Download summary PDF View on FDA.gov ↗

Adverse events under product code LOD

product code LOD

Death: 44
Injury: 3,004
Malfunction: 895
Other: 4
Total: 3,947

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.