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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, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer
510(k) Number K222566
Device Name Zimmer Persona Personalized Knee System
Zimmer, Inc.
1800 W Center Street
Warsaw,  IN  46580
Applicant Contact Lauren Ricker
Zimmer, Inc.
1800 W Center Street
Warsaw,  IN  46581
Correspondent Contact Lauren Ricker
Regulation Number888.3565
Classification Product Code
Subsequent Product Codes
Date Received08/24/2022
Decision Date 10/17/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No