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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 K173057
Device Name Zimmer Knee Joint Replacement Prostheses MR Labeling
Applicant
Zimmer, Inc.
P.O. Box 708
Warsaw,  IN  46581 -0708
Applicant Contact Jason Heckaman
Correspondent
Zimmer, Inc.
P.O. Box 708
Warsaw,  IN  46581 -0708
Correspondent Contact Jason Heckaman
Regulation Number888.3560
Classification Product Code
JWH  
Subsequent Product Codes
KRO   KRR   MBH  
Date Received09/28/2017
Decision Date 03/29/2018
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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