K252961
- 510(k) number
- K252961
- Device name
- Fusion FibFix Nail
- Applicant
- Fusion Orthopedics USA, LLC AZ · US
- Product code
- HSB — Rod, Fixation, Intramedullary And Accessories
- Decision date
- 2026-03-18
- Date received
- 2025-09-16
- 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: K252961.pdf
Official FDA record: K252961
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.