K253517
- 510(k) number
- K253517
- Device name
- Reselute Tibial Nail
- Applicant
- Reselute, Inc. NC · US
- Product code
- HSB — Rod, Fixation, Intramedullary And Accessories
- Decision date
- 2026-03-10
- Date received
- 2025-11-12
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K253517.pdf
Official FDA record: K253517
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.