K252106
- 510(k) number
- K252106
- Device name
- External Fixation Mini Rail System
- Applicant
- Paragon 28, Inc. CO · US
- Product code
- KTT — Appliance, Fixation, Nail/Blade/Plate Combination, M
- Decision date
- 2025-09-30
- Date received
- 2025-07-03
- 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: K252106.pdf
Official FDA record: K252106
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.