K251850
- 510(k) number
- K251850
- Device name
- Phantom® Hindfoot TTC/TC Nail System
- Applicant
- Paragon 28, Inc. CO · US
- Product code
- HSB — Rod, Fixation, Intramedullary And Accessories
- Decision date
- 2025-07-14
- Date received
- 2025-06-16
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.3 MB · U.S. public domain
Also available from FDA: K251850.pdf
Official FDA record: K251850
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.