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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 K191211
Device Name JOURNEY II Unicompartmental Knee System
Applicant
Smith & Nephew, Inc.
7135 Goodlett Farms Pkwy.
Cordova,  TN  38016
Applicant Contact Meenakshi Gupta
Correspondent
Smith & Nephew, Inc.
7135 Goodlett Farms Pkwy.
Cordova,  TN  38016
Correspondent Contact Meenakshi Gupta
Regulation Number888.3520
Classification Product Code
HSX  
Subsequent Product Codes
KRR   NPJ  
Date Received05/06/2019
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
Predetermined Change
Control Plan Authorized		 No
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