K232002
- 510(k) number
- K232002
- Device name
- Vantage® Total Ankle System
- Applicant
- Exactech, Inc. FL · US
- Product code
- HSN — Prosthesis, Ankle, Semi-Constrained, Cemented, Metal
- Decision date
- 2023-09-11
- Date received
- 2023-07-05
- 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: K232002.pdf
Official FDA record: K232002
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.