K232595
- 510(k) number
- K232595
- Device name
- Kinos Axiom Total Ankle System
- Applicant
- Restor3D NC · US
- Product code
- HSN — Prosthesis, Ankle, Semi-Constrained, Cemented, Metal
- Decision date
- 2023-11-28
- Date received
- 2023-08-25
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K232595.pdf
Official FDA record: K232595
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.