Device Classification Name |
Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
|
510(k) Number |
K003250 |
Device Name |
FMP METAL/METAL ACETABULAR INSERT |
Applicant |
ENCORE ORTHOPEDICS, INC. |
9800 METRIC BLVD. |
AUSTIN,
TX
78758
|
|
Applicant Contact |
DEBBIE DE LOS SANTOS |
Correspondent |
ENCORE ORTHOPEDICS, INC. |
9800 METRIC BLVD. |
AUSTIN,
TX
78758
|
|
Correspondent Contact |
DEBBIE DE LOS SANTOS |
Regulation Number | 888.3330
|
Classification Product Code |
|
Date Received | 10/17/2000 |
Decision Date | 01/25/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|