| Device Classification Name |
Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
More FDA Info for this Device |
| 510(K) Number |
K072121 |
| Device Name |
Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer |
| Applicant |
ZIMMER, INC.
P.O. BOX 708
WARSAW, IN 46581-0708 US
Other 510(k) Applications for this Company
|
| Contact |
PATRICIA JENKS
Other 510(k) Applications for this Contact |
| Regulation Number |
888.3310
More FDA Info for this Regulation Number |
| Classification Product Code |
KWZ
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
| Date Received |
08/01/2007 |
| Decision Date |
01/07/2008 |
| Decision |
SESE - SUBST EQUIV |
| Classification Advisory Committee |
OR - Orthopedic |
| Review Advisory Committee |
OR - Orthopedic |
| Statement / Summary / Purged Status |
Summary |
| Type |
Traditional |
| Reviewed By Third Party |
N |
| Expedited Review |
|