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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 K123459
Device Name ZIMMER PERSONA TM PERSONALIZED KNEE SYSTEM
Applicant
ZIMMER INC.
P.O. BOX 708
WARSAW,  IN  46581 -0708
Applicant Contact CAROL VIERLING, RAC
Correspondent
ZIMMER INC.
P.O. BOX 708
WARSAW,  IN  46581 -0708
Correspondent Contact CAROL VIERLING, RAC
Regulation Number888.3565
Classification Product Code
MBH  
Subsequent Product Codes
JWH   OIY  
Date Received11/09/2012
Decision Date 02/22/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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