510(k) K232303
ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM 3DP Technology by
Depuy Ireland UC
— Product Code MBH
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 11, 2023
- Date Received
- August 1, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
- Device Class
- Class II
- Regulation Number
- 888.3565
- Review Panel
- OR
- Submission Type