Depuy Synthes Femoral Neck System

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

Synthes (USA) Products, LLC

The following data is part of a premarket notification filed by Synthes (usa) Products, Llc with the FDA for Depuy Synthes Femoral Neck System.

Pre-market Notification Details

Device IDK182154
510k NumberK182154
Device Name:Depuy Synthes Femoral Neck System
ClassificationAppliance, Fixation, Nail/blade/plate Combination, Multiple Component
Applicant Synthes (USA) Products, LLC 1301 Goshen Parkway West Chester,  PA  19380
ContactStephan Jepards
CorrespondentStephan Jepards
Synthes (USA) Products, LLC 1301 Goshen Parkway West Chester,  PA  19380
Product CodeKTT  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-08-09
Decision Date2018-10-16
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.