510(k) K232595
K232595 is an FDA 510(k) premarket notification submitted by Restor3D for the device "Kinos Axiom Total Ankle System". The FDA issued a decision of Substantially Equivalent on November 28, 2023. The device falls under product code HSN (Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer), a Class II device regulated under 21 CFR 888.3110. Restor3D has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 28, 2023
- Date Received
- August 25, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
- Device Class
- Class II
- Regulation Number
- 888.3110
- Review Panel
- OR
- Submission Type