K240591
- 510(k) number
- K240591
- Device name
- restor3d Kinos Axiom Total Ankle System
- Applicant
- Restor3D, Inc. NC · US
- Product code
- HSN — Prosthesis, Ankle, Semi-Constrained, Cemented, Metal
- Decision date
- 2024-04-29
- Date received
- 2024-03-01
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
510(k) Summary (official FDA PDF): K240591.pdf
Official FDA record: K240591
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.