Device Classification Name |
Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
|
510(k) Number |
K040354 |
Device Name |
METAL/METAL HIP SYSTEM |
Applicant |
ENCORE MEDICAL, L.P. |
9800 METRIC BLVD. |
AUSTIN,
TX
78758
|
|
Applicant Contact |
DEBBIE DE LOS SANTOS |
Correspondent |
ENCORE MEDICAL, L.P. |
9800 METRIC BLVD. |
AUSTIN,
TX
78758
|
|
Correspondent Contact |
DEBBIE DE LOS SANTOS |
Regulation Number | 888.3330
|
Classification Product Code |
|
Date Received | 02/12/2004 |
Decision Date | 11/04/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|