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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 K210829
Device Name Persona Revision Knee System Femoral Metaphyseal Cones
Applicant
Zimmer, Inc.
1800 W. Center Street
warsaw,  IN  46580
Applicant Contact romil sheth
Correspondent
Zimmer, Inc.
1800 W. Center Street
warsaw,  IN  46580
Correspondent Contact romil sheth
Regulation Number888.3560
Classification Product Code
JWH  
Subsequent Product Code
MBH  
Date Received03/19/2021
Decision Date 05/18/2021
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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