Device Classification Name |
prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer
|
510(k) Number |
K140902 |
Device Name |
E1 SERIES A PATELLAE, STANDARD 3-PEG, E1 SERIES A PATELLAE, THIN 3-PEG, E1 SERIES PATELLAE, ASYMMETRICAL, 3-PEG |
Applicant |
BIOMET, INC. |
56 EAST BELL DR. |
BOX 587 |
WARSAW,
IN
46581 -0587
|
|
Applicant Contact |
AMY L WALRIVEN |
Correspondent |
BIOMET, INC. |
56 EAST BELL DR. |
BOX 587 |
WARSAW,
IN
46581 -0587
|
|
Correspondent Contact |
AMY L WALRIVEN |
Regulation Number | 888.3560
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 04/09/2014 |
Decision Date | 07/03/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|