K232169
- 510(k) number
- K232169
- Device name
- FITBONE® Transport and Lengthening System
- Applicant
- Orthofix Srl IT
- Product code
- HSB — Rod, Fixation, Intramedullary And Accessories
- Decision date
- 2024-03-22
- Date received
- 2023-07-21
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.5 MB · U.S. public domain
Also available from FDA: K232169.pdf
Official FDA record: K232169
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.