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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 K221479
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 Codes
MBH   OIY  
Date Received05/23/2022
Decision Date 11/17/2022
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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