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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 K191625
Device Name Persona Revision Knee System
Applicant
Zimmer, Inc.
1800 W. Center St.
Warsaw,  IN  46580
Applicant Contact Nicole Meredith
Correspondent
Zimmer, Inc.
1800 W. Center St.
Warsaw,  IN  46580
Correspondent Contact Nicole Meredith
Regulation Number888.3560
Classification Product Code
JWH  
Subsequent Product Codes
MBH   OIY  
Date Received06/18/2019
Decision Date 09/05/2019
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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