K251862
- 510(k) number
- K251862
- Device name
- External Fixation Bone Distractor
- Applicant
- Paragon 28, Inc. CO · US
- Product code
- KTT — Appliance, Fixation, Nail/Blade/Plate Combination, M
- Decision date
- 2025-08-11
- Date received
- 2025-06-17
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K251862.pdf
Official FDA record: K251862
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.