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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 K152494
Device Name Zimmer NexGen Complete Knee Solution Tibial and Femoral Augments
Applicant
Zimmer, Inc.
P.O. Box 708
Warsaw,  IN  46581 -0708
Applicant Contact MARK D WARNER
Correspondent
Zimmer, Inc.
P.O. Box 708
Warsaw,  IN  46581 -0708
Correspondent Contact MARK D WARNER
Regulation Number888.3560
Classification Product Code
JWH  
Subsequent Product Code
KRO  
Date Received09/01/2015
Decision Date 11/25/2015
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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