GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM; NEX GEN COMPLETE KNEE SOLUTION CR-FLEX GENDER SOLUTIONS FEMALE FEMORAL COMPON

Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer

ZIMMER, INC.

The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Gender Solutions Natural-knee Flex System; Nex Gen Complete Knee Solution Cr-flex Gender Solutions Female Femoral Compon.

Pre-market Notification Details

Device IDK071107
510k NumberK071107
Device Name:GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM; NEX GEN COMPLETE KNEE SOLUTION CR-FLEX GENDER SOLUTIONS FEMALE FEMORAL COMPON
ClassificationProsthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer
Applicant ZIMMER, INC. P.O. BOX 708 Warsaw,  IN  46581 -0708
ContactBrandon Hipsher
CorrespondentBrandon Hipsher
ZIMMER, INC. P.O. BOX 708 Warsaw,  IN  46581 -0708
Product CodeMBH  
CFR Regulation Number888.3565 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-04-19
Decision Date2007-07-06
Summary:summary

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