Device Classification Name |
prosthesis, shoulder, non-constrained, metal/polymer cemented
|
510(k) Number |
K042321 |
Device Name |
MOSAIC NON-MODULAR PROXIMAL BODY AND EAS OFFSET MODULAR HUMERAL HEAD |
Applicant |
BIOMET MANUFACTURING CORP. |
56 EAST BELL DRIVE |
PO BOX 587 |
WARSAW,
IN
46581 -0587
|
|
Applicant Contact |
KACY ARNOLD |
Correspondent |
BIOMET MANUFACTURING CORP. |
56 EAST BELL DRIVE |
PO BOX 587 |
WARSAW,
IN
46581 -0587
|
|
Correspondent Contact |
KACY ARNOLD |
Regulation Number | 888.3650
|
Classification Product Code |
|
Date Received | 08/26/2004 |
Decision Date | 01/28/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|