| Device Classification Name |
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
More FDA Info for this Device |
| 510(K) Number |
K060707 |
| Device Name |
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented |
| Applicant |
AESCULAP, INC.
3773 Corporate Parkway
Center Valley, PA 18034 US
Other 510(k) Applications for this Company
|
| Contact |
MATTHEW M HULL
Other 510(k) Applications for this Contact |
| Regulation Number |
888.3390
More FDA Info for this Regulation Number |
| Classification Product Code |
KWY
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
| Date Received |
03/16/2006 |
| Decision Date |
05/31/2006 |
| 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 |
|