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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 ROAD
MEMPHIS,  TN  38116
Applicant Contact NICHOLAS B TABRIZI
Correspondent
SMITH & NEPHEW, INC.
1450 E BROOKS ROAD
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
Recalls CDRH Recalls
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