Device Classification Name |
prosthesis, knee, femorotibial, non-constrained, cemented, metal/polymer
|
510(k) Number |
K160738 |
Device Name |
ZUK Select Knee System |
Applicant |
SMITH & NEPHEW, INC. |
7135 GOODLETT FARMS PARKWAY |
CORDOVA,
TN
38016
|
|
Applicant Contact |
BRAD SHEALS |
Correspondent |
SMITH & NEPHEW, INC. |
7135 GOODLETT FARMS PARKWAY |
CORDOVA,
TN
38016
|
|
Correspondent Contact |
BRAD SHEALS |
Regulation Number | 888.3520
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 03/17/2016 |
Decision Date | 06/15/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|