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 IDK201379
510k NumberK201379
Device Name:Artemis Proximal Femoral Nail System
ClassificationRod, Fixation, Intramedullary And Accessories
Applicant GLW, Inc. 300 Sylvan Avenue Englewood Cliffs,  NJ  07632
ContactArundhati Radhakrishnan
CorrespondentNancy Lincé
Lincé Consulting, LLC 111 Deerwood Road, Suite 200 San Ramon,  CA  95483
Product CodeHSB  
CFR Regulation Number888.3020 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-05-26
Decision Date2021-02-19

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