K250197
- 510(k) number
- K250197
- Device name
- Estremo Fibular Nail
- Applicant
- Citieffe S.R.L. IT
- Product code
- HSB — Rod, Fixation, Intramedullary And Accessories
- Decision date
- 2025-10-17
- Date received
- 2025-01-23
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K250197.pdf
Official FDA record: K250197
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.