K240475
- 510(k) number
- K240475
- Device name
- Hintermann Series H2 Total Ankle System
- Applicant
- Vilex, LLC TN · US
- Product code
- HSN — Prosthesis, Ankle, Semi-Constrained, Cemented, Metal
- Decision date
- 2024-12-02
- Date received
- 2024-02-20
- 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: K240475.pdf
Official FDA record: K240475
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.