K242247
- 510(k) number
- K242247
- Device name
- ARIX Femur Nail System
- Applicant
- Jeil Medical Corporation KR
- Product code
- HSB — Rod, Fixation, Intramedullary And Accessories
- Decision date
- 2025-04-22
- Date received
- 2024-07-31
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K242247.pdf
Official FDA record: K242247
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.