K250933
- 510(k) number
- K250933
- Device name
- LORRAINE 2.5/3.5mm Distal Humerus System
- Applicant
- Bonebridge AG CH
- Product code
- HRS — Plate, Fixation, Bone
- Decision date
- 2025-06-11
- Date received
- 2025-03-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.3 MB · U.S. public domain
Also available from FDA: K250933.pdf
Official FDA record: K250933
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.