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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
Contact kelli anderson
Regulation Number888.3560
Classification Product Code
JWH  
Date Received11/15/2011
Decision Date 03/27/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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