Device Classification Name |
prosthesis, hip, semi-constrained (metal uncemented acetabular component)
|
510(k) Number |
K063414 |
Device Name |
MODIFICATION TO: FMP METAL/METAL ACETABULAR INSERT, MODELS 499-28, 499-34, 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 |
|
Date Received | 11/13/2006 |
Decision Date | 12/12/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|