Phantom® Hindfoot TTC/TC Nail System

Rod, Fixation, Intramedullary And Accessories

Paragon 28, Inc.

The following data is part of a premarket notification filed by Paragon 28, Inc. with the FDA for Phantom® Hindfoot Ttc/tc Nail System.

Pre-market Notification Details

Device IDK201227
510k NumberK201227
Device Name:Phantom® Hindfoot TTC/TC Nail System
ClassificationRod, Fixation, Intramedullary And Accessories
Applicant Paragon 28, Inc. 14445 Grasslands Dr. Englewood,  CO  80112
ContactHaylie Hertz
CorrespondentSamuel Pollard
MCRA, LLC 1050 K St NW Suite 1000 Washington,  DC  20001
Product CodeHSB  
CFR Regulation Number888.3020 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-05-06
Decision Date2020-07-17

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