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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
510(k) Number K190085
Device Name Journey II Unicompartmental Knee System
Applicant
Smith & Nephew Inc
7135 Goodlett Farms Parkway
Cordova,  TN  38016
Applicant Contact Amy Winegarden
Correspondent
Smith & Nephew Inc
7135 Goodlett Farms Parkway
Cordova,  TN  38016
Correspondent Contact Amy Winegarden
Regulation Number888.3520
Classification Product Code
HSX  
Subsequent Product Codes
KRR   NPJ  
Date Received01/17/2019
Decision Date 02/11/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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