K252025
- 510(k) number
- K252025
- Device name
- Active Intramedullary (AIM) Tibial Nail System
- Applicant
- Satori Orthopaedics, Inc. AZ · US
- Product code
- HSB — Rod, Fixation, Intramedullary And Accessories
- Decision date
- 2026-03-04
- Date received
- 2025-06-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K252025.pdf
Official FDA record: K252025
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.