K250112
- 510(k) number
- K250112
- Device name
- FitboneTM Trochanteric
- Applicant
- Orthofix Srl IT
- Product code
- HSB — Rod, Fixation, Intramedullary And Accessories
- Decision date
- 2025-04-10
- Date received
- 2025-01-16
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K250112.pdf
Official FDA record: K250112
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.