K252826
- 510(k) number
- K252826
- Device name
- ARIX Femur Nail System
- Applicant
- Jeil Medical Corporation KR
- Product code
- HSB — Rod, Fixation, Intramedullary And Accessories
- Decision date
- 2025-12-10
- Date received
- 2025-09-05
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
510(k) Summary (official FDA PDF): K252826.pdf
Official FDA record: K252826
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.