K253155
- 510(k) number
- K253155
- Device name
- Fule Metallic Lockable Intramedullary Nail Systems
- Applicant
- Beijing Fule Science & Technology Development Co., Ltd. CN
- Product code
- HSB — Rod, Fixation, Intramedullary And Accessories
- Decision date
- 2026-06-17
- Date received
- 2025-09-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.4 MB · U.S. public domain
Also available from FDA: K253155.pdf
Official FDA record: K253155
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.