Device Classification Name |
Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
|
510(k) Number |
K191211 |
Device Name |
JOURNEY II Unicompartmental Knee System |
Applicant |
Smith & Nephew, Inc. |
7135 Goodlett Farms Parkway |
Cordova,
TN
38016
|
|
Applicant Contact |
Meenakshi Gupta |
Correspondent |
Smith & Nephew, Inc. |
7135 Goodlett Farms Parkway |
Cordova,
TN
38016
|
|
Correspondent Contact |
Meenakshi Gupta |
Regulation Number | 888.3520
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 05/06/2019 |
Decision Date | 07/25/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|