Device Classification Name |
Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)
|
510(k) Number |
K042841 |
FOIA Releasable 510(k) |
K042841
|
Device Name |
M2A/C2A ACETABULAR SYSTEM |
Applicant |
BIOMET, INC. |
56 EAST BELL DR. |
P.O. BOX 587 |
WARSAW,
IN
46582
|
|
Applicant Contact |
PATRICIA S ANDBORN BERES |
Correspondent |
BIOMET, INC. |
56 EAST BELL DR. |
P.O. BOX 587 |
WARSAW,
IN
46582
|
|
Correspondent Contact |
PATRICIA S ANDBORN BERES |
Regulation Number | 888.3320
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 10/14/2004 |
Decision Date | 12/21/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|