Device Classification Name |
Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
|
510(k) Number |
K033634 |
Device Name |
EPSILON METASUL 32MM ACETABULAR INSERTS, STANDARD AND HOODED |
Applicant |
CENTERPULSE ORTHOPEDICS, INC. |
9900 SPECTRUM DR. |
AUSTIN,
TX
78717
|
|
Applicant Contact |
AUDREY SWEARINGEN |
Correspondent |
CENTERPULSE ORTHOPEDICS, INC. |
9900 SPECTRUM DR. |
AUSTIN,
TX
78717
|
|
Correspondent Contact |
AUDREY SWEARINGEN |
Regulation Number | 888.3330
|
Classification Product Code |
|
Date Received | 11/19/2003 |
Decision Date | 09/15/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|