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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 K113369
Device Name ZIMMER PERSONA KNEE SYSTEM
Applicant
ZIMMER INC.
P.O. BOX 708
WARSAW,  IN  46581 -0708
Applicant Contact KELLI ANDERSON
Correspondent
ZIMMER INC.
P.O. BOX 708
WARSAW,  IN  46581 -0708
Correspondent Contact KELLI ANDERSON
Regulation Number888.3560
Classification Product Code
JWH  
Date Received11/15/2011
Decision Date 03/27/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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