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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 K872379
Device Name INSALL/BURSTEIN* II MODULAR TOTAL KNEE
Original Applicant
ZIMMER, INC.
p.o. box 708
warsaw,  IN  46581 0708
Original Contact max sherman
Regulation Number888.3560
Classification Product Code
JWH  
Date Received06/19/1987
Decision Date 10/28/1987
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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