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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 K093746
Device Name VERILAST WEAR CLAIMS FOR THE LEGION PRIMARY KNEE SYSTEM
Applicant
Smith & Nephew, Inc.
1450 E. Brooks Rd.
Memphis,  TN  38116
Applicant Contact JASON SELLS
Correspondent
Smith & Nephew, Inc.
1450 E. Brooks Rd.
Memphis,  TN  38116
Correspondent Contact JASON SELLS
Regulation Number888.3560
Classification Product Code
JWH  
Date Received12/04/2009
Decision Date 04/14/2010
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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