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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 K121771
Device Name ZIMMER PERSONA THE PERSONALIZED KNEE SYSTEM
Original Applicant
ZIMMER, INC.
p.o. box 708
warsaw,  IN  46581 -0708
Original Contact kelli j anderson
Regulation Number888.3565
Classification Product Code
MBH  
Subsequent Product Codes
JWH   OIY  
Date Received06/15/2012
Decision Date 11/07/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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