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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, Constrained, Cemented, Metal/Polymer
510(k) Number K081111
Device Name LEGION HINGE KNEE SYSTEM
Applicant
Smith & Nephew, Inc.
1450 E. Brooks Rd.
Memphis,  TN  38116
Applicant Contact NICHOLAS B TABRIZI
Correspondent
Smith & Nephew, Inc.
1450 E. Brooks Rd.
Memphis,  TN  38116
Correspondent Contact NICHOLAS B TABRIZI
Regulation Number888.3510
Classification Product Code
KRO  
Date Received04/18/2008
Decision Date 07/23/2008
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
Recalls CDRH Recalls
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