Device Classification Name |
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
|
510(k) Number |
K130126 |
FOIA Releasable 510(k) |
K130126
|
Device Name |
SIGNATURE PERSONALIZED PATIENT CARE SYSTEM - GLENOID GUIDE SYSTEM |
Applicant |
BIOMET, INC. |
56 EAST BELL DR. |
BOX 587 |
WARSAW,
IN
46581 -0587
|
|
Applicant Contact |
TRACY B JOHNSON |
Correspondent |
BIOMET, INC. |
56 EAST BELL DR. |
BOX 587 |
WARSAW,
IN
46581 -0587
|
|
Correspondent Contact |
TRACY B JOHNSON |
Regulation Number | 888.3670
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 01/17/2013 |
Decision Date | 08/06/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|