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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 K113482
Device Name JOURNEY II DEEP DISHED ARTICULAR INSERTS
Applicant
Smith & Nephew, Inc.
1450 Brooks Rd.
Memphus,  TN  38116
Applicant Contact SHEREEN MYERS
Correspondent
Smith & Nephew, Inc.
1450 Brooks Rd.
Memphus,  TN  38116
Correspondent Contact SHEREEN MYERS
Regulation Number888.3560
Classification Product Code
JWH  
Date Received11/23/2011
Decision Date 02/27/2012
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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