Device Classification Name |
Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
|
510(k) Number |
K070221 |
Device Name |
FMP METAL/METAL ACETABULAR INSERT, 499-28,449-34, 499-38 |
Applicant |
ENCORE MEDICAL, L.P. |
9800 METRIC BLVD. |
AUSTIN,
TX
78758
|
|
Applicant Contact |
TEFFANY HUTTO |
Correspondent |
ENCORE MEDICAL, L.P. |
9800 METRIC BLVD. |
AUSTIN,
TX
78758
|
|
Correspondent Contact |
TEFFANY HUTTO |
Regulation Number | 888.3330
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 01/24/2007 |
Decision Date | 04/04/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|