Device Classification Name |
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
More FDA Info for this Device |
510(K) Number |
K964178 |
Device Name |
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented |
Applicant |
ENCORE ORTHOPEDICS, INC.
8900 SHOAL CREEK BLVD.,
BLDG. 300
AUSTIN, TX 78757 US
Other 510(k) Applications for this Company
|
Contact |
ASHLEY M BOCK
Other 510(k) Applications for this Contact |
Regulation Number |
888.3360
More FDA Info for this Regulation Number |
Classification Product Code |
LWJ
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
Date Received |
10/18/1996 |
Decision Date |
05/05/1997 |
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 |
|