510(k) K945589
CONSENSUS(TM) KNEE COBALT CHROME NONPOROUS STEMMED TIBIAL BASEPLATE by
U.S. Medical Products, Inc.
— Product Code JWH
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 31, 1995
- Date Received
- November 14, 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