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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 K181947
Device Name Persona Revision Knee System
Zimmer Inc.
P.O. Box 708
Warsaw,  IN  46581 -0708
Applicant Contact Nicole Meredith
Zimmer Inc.
P.O. Box 708
Warsaw,  IN  46581 -0708
Correspondent Contact Nicole Meredith
Regulation Number888.3560
Classification Product Code
Subsequent Product Codes
Date Received07/20/2018
Decision Date 10/25/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No