Device Classification Name |
Shoulder Prosthesis, Reverse Configuration
|
510(k) Number |
K131353 |
Device Name |
COMPREHENSIVE REVERSE SHOULDER - TITANIUM GLENOSPHERE |
Applicant |
BIOMET MANUFACTURING CORP. |
56 EAST BELL DRIVE |
WARSAW,
IN
46582
|
|
Applicant Contact |
PATRICIA S BERES |
Correspondent |
BIOMET MANUFACTURING CORP. |
56 EAST BELL DRIVE |
WARSAW,
IN
46582
|
|
Correspondent Contact |
PATRICIA S BERES |
Regulation Number | 888.3660
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 05/10/2013 |
Decision Date | 10/08/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|