Device Classification Name |
shoulder prosthesis, reverse configuration
|
510(k) Number |
K113069 |
Device Name |
COMPREHENSIVE REVERSE SHOULDER HUMERAL TRAY |
Applicant |
BIOMET MANUFACTURING CORP. |
56 BELL DRIVE |
WARSAW,
IN
46580
|
|
Applicant Contact |
PATRICIA S BERES |
Correspondent |
BIOMET MANUFACTURING CORP. |
56 BELL DRIVE |
WARSAW,
IN
46580
|
|
Correspondent Contact |
PATRICIA S BERES |
Regulation Number | 888.3660
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 10/17/2011 |
Decision Date | 01/11/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|