DePuy Synthes Femoral Neck System

Appliance, Fixation, Nail/blade/plate Combination, Multiple Component

DePuy Synthes

The following data is part of a premarket notification filed by Depuy Synthes with the FDA for Depuy Synthes Femoral Neck System.

Pre-market Notification Details

Device IDK172872
510k NumberK172872
Device Name:DePuy Synthes Femoral Neck System
ClassificationAppliance, Fixation, Nail/blade/plate Combination, Multiple Component
Applicant DePuy Synthes Luzernstrasse 21 Zuchwil,  CH 4528
ContactAna Sala Roca
CorrespondentAna Sala Roca
DePuy Synthes Luzernstrasse 21 Zuchwil,  CH 4528
Product CodeKTT  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-09-21
Decision Date2018-03-05
Summary:summary

NIH GUDID Devices

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