K250641
- 510(k) number
- K250641
- Device name
- APEX 3D Total Ankle Replacement System
- Applicant
- Paragon 28, Inc. CO · US
- Product code
- HSN — Prosthesis, Ankle, Semi-Constrained, Cemented, Metal
- Decision date
- 2025-05-01
- Date received
- 2025-03-04
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.3 MB · U.S. public domain
Also available from FDA: K250641.pdf
Official FDA record: K250641
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.