Artemis Proximal Femoral Nail System

Rod, Fixation, Intramedullary And Accessories

GLW, Inc.

The following data is part of a premarket notification filed by Glw, Inc. with the FDA for Artemis Proximal Femoral Nail System.

Pre-market Notification Details

Device IDK221489
510k NumberK221489
Device Name:Artemis Proximal Femoral Nail System
ClassificationRod, Fixation, Intramedullary And Accessories
Applicant GLW, Inc. 300 Sylvan Avenue Englewood Cliffs,  NJ  07632
ContactArundhati Radhakrishnan
CorrespondentCheryl Wagoner
Wagoner Consulting LLC 5215 Crosswinds Drive Wilmington,  NC  28409
Product CodeHSB  
CFR Regulation Number888.3020 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-05-23
Decision Date2022-10-27

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