K253613
- 510(k) number
- K253613
- Device name
- Monkey Rings External Ring Fixation System
- Applicant
- Paragon 28, Inc. CO · US
- Product code
- KTT — Appliance, Fixation, Nail/Blade/Plate Combination, M
- Decision date
- 2025-12-19
- Date received
- 2025-11-18
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain
Also available from FDA: K253613.pdf
Official FDA record: K253613
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.