510(k) K941769
Clearance Details
- Decision
- SN ()
- Decision Date
- February 1, 1995
- Date Received
- April 11, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- Device Class
- Class II
- Regulation Number
- 888.3560
- Review Panel
- OR
- Submission Type