Device Classification Name |
Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
|
510(k) Number |
K050251 |
Device Name |
BALANCE HIP SYSTEM |
Applicant |
BIOMET, INC. |
56 EAST BELL DR. |
BOX 587 |
WARSAW,
IN
46581 -0587
|
|
Applicant Contact |
GARY BAKER |
Correspondent |
BIOMET, INC. |
56 EAST BELL DR. |
BOX 587 |
WARSAW,
IN
46581 -0587
|
|
Correspondent Contact |
GARY BAKER |
Regulation Number | 888.3330
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 02/03/2005 |
Decision Date | 05/27/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|