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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 K070214
Device Name GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM
Original Applicant
ZIMMER, INC.
p.o. box 708
warsaw,  IN  46581 0708
Original Contact brandon hipsher
Regulation Number888.3565
Classification Product Code
MBH  
Subsequent Product Code
JWH  
Date Received01/23/2007
Decision Date 03/16/2007
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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