K260146
- 510(k) number
- K260146
- Device name
- FITBONE® TRANSPORT AND LENGTHENING SYSTEM
- Applicant
- Orthofix Srl IT
- Product code
- HSB — Rod, Fixation, Intramedullary And Accessories
- Decision date
- 2026-05-19
- Date received
- 2026-01-20
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K260146.pdf
Official FDA record: K260146
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.