K250559
- 510(k) number
- K250559
- Device name
- GMReis Fibula Nail System
- Applicant
- Gm Dos Reis Industria E Comercio BR
- Product code
- HSB — Rod, Fixation, Intramedullary And Accessories
- Decision date
- 2025-06-12
- Date received
- 2025-02-25
- 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: K250559.pdf
Official FDA record: K250559
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.