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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 K071107
Device Name GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM; NEX GEN COMPLETE KNEE SOLUTION CR-FLEX GENDER SOLUTIONS FEMALE FEMORAL COMPON
Applicant
ZIMMER, INC.
P.O. BOX 708
warsaw,  IN  46581 -0708
Applicant Contact brandon hipsher
Correspondent
ZIMMER, INC.
P.O. BOX 708
warsaw,  IN  46581 -0708
Correspondent Contact brandon hipsher
Regulation Number888.3565
Classification Product Code
MBH  
Subsequent Product Code
JWH  
Date Received04/19/2007
Decision Date 07/06/2007
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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