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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 K242711
Device Name JOURNEY II Unicompartmental Knee System (JOURNEY II UK)
Applicant
Smith & Nephew, Inc.
1450 Brooks Rd.
Memphus,  TN  38116
Applicant Contact Anne Remington
Correspondent
Smith & Nephew, Inc.
1450 Brooks Rd.
Memphus,  TN  38116
Correspondent Contact Anne Remington
Regulation Number888.3520
Classification Product Code
HSX  
Subsequent Product Codes
KRR   NPJ  
Date Received09/09/2024
Decision Date 10/30/2024
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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