K234128
- 510(k) number
- K234128
- Device name
- Phantom Fibula Nail System
- Applicant
- Paragon 28, Inc. CO · US
- Product code
- HSB — Rod, Fixation, Intramedullary And Accessories
- Decision date
- 2024-08-22
- Date received
- 2023-12-28
- 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: K234128.pdf
Official FDA record: K234128
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.