510(k) K233980
ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System, Sigma High Performance (HP) Partial Knee System by
Depuy Ireland UC
— Product Code KRO
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 21, 2024
- Date Received
- December 18, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
- Device Class
- Class II
- Regulation Number
- 888.3510
- Review Panel
- OR
- Submission Type