Device Classification Name |
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
|
510(k) Number |
K060694 |
Device Name |
MODULAR HYBRID GLENOID |
Applicant |
BIOMET MANUFACTURING CORP. |
PO BOX 587 |
WARSAW,
IN
46581 -0587
|
|
Applicant Contact |
PATRICIA SANDBORN BERES |
Correspondent |
BIOMET MANUFACTURING CORP. |
PO BOX 587 |
WARSAW,
IN
46581 -0587
|
|
Correspondent Contact |
PATRICIA SANDBORN BERES |
Regulation Number | 888.3660
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 03/15/2006 |
Decision Date | 12/11/2006 |
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
|
|
|