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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/Femoral, Semi-Constrained, Cemented, Metal/Polymer
510(k) Number K070695
Device Name ZIMMER PATELLOFEMORAL JOINT PROSTHESIS
Applicant
Zimmer, Inc.
P.O. Box 708
Warsaw,  IN  46581 -0708
Applicant Contact DALENE BINKLEY
Correspondent
Zimmer, Inc.
P.O. Box 708
Warsaw,  IN  46581 -0708
Correspondent Contact DALENE BINKLEY
Regulation Number888.3540
Classification Product Code
KRR  
Date Received03/13/2007
Decision Date 06/07/2007
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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