Device Classification Name |
prosthesis, shoulder, non-constrained, metal/polymer cemented
|
510(k) Number |
K872454 |
Device Name |
BIOMET MODULAR SHOULDER PROSTHESIS |
Applicant |
BIOMET, INC. |
P.O. BOX 587 |
WARSAW,
IN
46581 -0587
|
|
Applicant Contact |
LONNIE WITHAM |
Correspondent |
BIOMET, INC. |
P.O. BOX 587 |
WARSAW,
IN
46581 -0587
|
|
Correspondent Contact |
LONNIE WITHAM |
Regulation Number | 888.3650
|
Classification Product Code |
|
Date Received | 06/23/1987 |
Decision Date | 08/27/1987 |
Decision |
SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS
(SN) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|