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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 K112941
Device Name LEGION NARROW OXINIUM CRUCIATE RETAINING AND POSTERIOR STABILIZED FENORAL COMPONENTS
Applicant
Smith & Nephew, Inc.
7135 Goodlett Farms Pkwy.
Memphis,  TN  38016
Applicant Contact DAVID HENLEY
Correspondent
Smith & Nephew, Inc.
7135 Goodlett Farms Pkwy.
Memphis,  TN  38016
Correspondent Contact DAVID HENLEY
Regulation Number888.3560
Classification Product Code
JWH  
Date Received10/04/2011
Decision Date 12/20/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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