K231343
- 510(k) number
- K231343
- Device name
- Redemption Duo Hindfoot Nail System
- Applicant
- Vilex, LLC TN · US
- Product code
- HSB — Rod, Fixation, Intramedullary And Accessories
- Decision date
- 2024-01-30
- Date received
- 2023-05-09
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K231343.pdf
Official FDA record: K231343
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.