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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 K162775
Device Name Legion Cone System
Smith & Nephew, Inc.
7135 Goodlett Farms Parkway
Cordova,  TN  38016
Applicant Contact Natalie Williams
Smith & Nephew, Inc.
1450 Brooks Road
Memphis,  TN  38116
Correspondent Contact Dongeun Kim
Regulation Number888.3560
Classification Product Code
Subsequent Product Code
Date Received10/03/2016
Decision Date 01/13/2017
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