| Device Classification Name |
Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
More FDA Info for this Device |
| 510(K) Number |
K062301 |
| Device Name |
Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer |
| Applicant |
DEPUY ORTHOPAEDICS, INC.
700 ORTHOPAEDIC DR.
P.O BOX 988
WARSAW, IN 46581-0988 US
Other 510(k) Applications for this Company
|
| Contact |
NANCY FRIDDLE
Other 510(k) Applications for this Contact |
| Regulation Number |
888.3510
More FDA Info for this Regulation Number |
| Classification Product Code |
KRO
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
| Date Received |
08/08/2006 |
| Decision Date |
10/13/2006 |
| Decision |
SESE - SUBST EQUIV |
| Classification Advisory Committee |
OR - Orthopedic |
| Review Advisory Committee |
OR - Orthopedic |
| Statement / Summary / Purged Status |
Summary |
| Type |
Special |
| Reviewed By Third Party |
N |
| Expedited Review |
|