Device Classification Name |
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
|
510(k) Number |
K953510 |
Device Name |
HIP JOINT FEMORAL (HEMI-HIP) METAL/POLYMER CEMENTED OR UNCEMENTED PROSTHESIS |
Applicant |
ENCORE ORTHOPEDICS, INC. |
8920 BUSINESS PARK DR. |
SUTIE 380 |
AUSTIN,
TX
78759
|
|
Applicant Contact |
J.D. WEBB |
Correspondent |
ENCORE ORTHOPEDICS, INC. |
8920 BUSINESS PARK DR. |
SUTIE 380 |
AUSTIN,
TX
78759
|
|
Correspondent Contact |
J.D. WEBB |
Regulation Number | 888.3390
|
Classification Product Code |
|
Date Received | 07/26/1995 |
Decision Date | 08/09/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|