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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 K193223
Device Name Persona Personalized Knee System
Applicant
Zimmer, Inc
1800 W. Center Street
warsaw,  IN  46580
Applicant Contact gregory foster
Correspondent
Zimmer, Inc
1800 W. Center Street
warsaw,  IN  46580
Correspondent Contact gregory foster
Regulation Number888.3560
Classification Product Code
JWH  
Subsequent Product Code
OIY  
Date Received11/22/2019
Decision Date 01/24/2020
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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