K242452
- 510(k) number
- K242452
- Device name
- Monkey Bars Pin to Bar External Fixation System
- Applicant
- Paragon 28, Inc. CO · US
- Product code
- KTT — Appliance, Fixation, Nail/Blade/Plate Combination, M
- Decision date
- 2024-11-01
- Date received
- 2024-08-19
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K242452.pdf
Official FDA record: K242452
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.