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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, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
510(k) Number K173331
Device Name JOURNEY II XR Knee Instruments
Applicant
Smith & Nephew, Inc.
1450 E. Brooks Road
Memphis,  TN  38116
Applicant Contact Shereen Bienz
Correspondent
Smith & Nephew, Inc.
1450 E. Brooks Road
Memphis,  TN  38116
Correspondent Contact Shereen Bienz
Regulation Number888.3560
Classification Product Code
JWH  
Date Received10/23/2017
Decision Date 11/16/2017
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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