CONQUEST FN

Device, Fixation, Proximal Femoral, Implant

Smith & Nephew, Inc.

The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Conquest Fn.

Pre-market Notification Details

Device IDK193029
510k NumberK193029
Device Name:CONQUEST FN
ClassificationDevice, Fixation, Proximal Femoral, Implant
Applicant Smith & Nephew, Inc. 1450 E Brooks Rd Memphis,  TN  38116
ContactThomas Fearnley
CorrespondentThomas Fearnley
Smith & Nephew, Inc. 1450 E Brooks Rd Memphis,  TN  38116
Product CodeJDO  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyOrthopedic
510k Review PanelOrthopedic
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-10-30
Decision Date2020-02-28

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00885556720813 K193029 000
00885556720806 K193029 000

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.