TELEGRAPH® EVOLUTION Humeral Nailing System

Rod, Fixation, Intramedullary And Accessories

FH Industrie

The following data is part of a premarket notification filed by Fh Industrie with the FDA for Telegraph® Evolution Humeral Nailing System.

Pre-market Notification Details

Device IDK200127
510k NumberK200127
Device Name:TELEGRAPH® EVOLUTION Humeral Nailing System
ClassificationRod, Fixation, Intramedullary And Accessories
Applicant FH Industrie ZI De Kernevez - 6 Rue Nobel Quimper,  FR 29000
ContactPatricia Donnard
CorrespondentKathy L. Remsen
MRC-X, LLC 9085 East Mineral Circle, Suite 110 Centennial,  CO  80112
Product CodeHSB  
CFR Regulation Number888.3020 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-01-21
Decision Date2020-10-01

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