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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 Parkway
Cordova,  TN  38016
Applicant Contact DAVID HENLEY
Correspondent
SMITH & NEPHEW, INC.
7135 Goodlett Farms Parkway
Cordova,  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
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