K260900
- 510(k) number
- K260900
- Device name
- DYNEX® External Fixation Systems
- Applicant
- Vilex, LLC TN · US
- Product code
- KTT — Appliance, Fixation, Nail/Blade/Plate Combination, M
- Decision date
- 2026-04-17
- Date received
- 2026-03-18
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K260900.pdf
Official FDA record: K260900
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.