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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
Applicant
ZIMMER, INC.
P.O. BOX 708
WARSAW,  IN  46581 -0708
Applicant Contact KELLI J ANDERSON
Correspondent
ZIMMER, INC.
P.O. BOX 708
WARSAW,  IN  46581 -0708
Correspondent 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
Recalls CDRH Recalls
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