510(k) K253328
GMK 3D Metal Tibial Tray Extension by
Medacta International S.A.
— Product Code MBH
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 26, 2026
- Date Received
- September 30, 2025
- 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