Device Classification Name |
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
More FDA Info for this Device |
510(K) Number |
K130126 |
Device Name |
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented |
Applicant |
BIOMET, INC.
56 EAST BELL DR.
BOX 587
WARSAW, IN 46581-0587 US
Other 510(k) Applications for this Company
|
Contact |
TRACY B JOHNSON
Other 510(k) Applications for this Contact |
Regulation Number |
888.3670
More FDA Info for this Regulation Number |
Classification Product Code |
MBF
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
Date Received |
01/17/2013 |
Decision Date |
08/06/2013 |
Decision |
SESE - SUBST EQUIV |
Classification Advisory Committee |
OR - Orthopedic |
Review Advisory Committee |
OR - Orthopedic |
Statement / Summary / Purged Status |
Summary |
Type |
Traditional |
Reviewed By Third Party |
N |
Expedited Review |
|