Device Classification Name |
prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer
|
510(k) Number |
K200227 |
Device Name |
Journey II XR Knee Instrument |
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 |
Brad Sheals |
Regulation Number | 888.3560
|
Classification Product Code |
|
Date Received | 01/30/2020 |
Decision Date | 06/04/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|