K254107
- 510(k) number
- K254107
- Device name
- Refobacin Bone Cement R (110034355)
- Applicant
- Biomet France FR
- Product code
- LOD — Bone Cement
- Decision date
- 2026-04-15
- Date received
- 2025-12-19
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K254107.pdf
Official FDA record: K254107
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.