Device Classification Name |
Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
|
510(k) Number |
K042093 |
Device Name |
VANGUARD M SERIES UNICONDYLAR TIBIAL BEARINGS |
Applicant |
BIOMET, INC. |
56 EAST BELL DR. |
BOX 587 |
WARSAW,
IN
46581 -0587
|
|
Applicant Contact |
TAACY BICKEL JOHNSON |
Correspondent |
BIOMET, INC. |
56 EAST BELL DR. |
BOX 587 |
WARSAW,
IN
46581 -0587
|
|
Correspondent Contact |
TAACY BICKEL JOHNSON |
Regulation Number | 888.3530
|
Classification Product Code |
|
Date Received | 08/03/2004 |
Decision Date | 11/01/2004 |
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
|
|
|