PediFlex Flexible Nail System

Pin, Fixation, Smooth

OrthoPediatrics Corp.

The following data is part of a premarket notification filed by Orthopediatrics Corp. with the FDA for Pediflex Flexible Nail System.

Pre-market Notification Details

Device IDK201838
510k NumberK201838
Device Name:PediFlex Flexible Nail System
ClassificationPin, Fixation, Smooth
Applicant OrthoPediatrics Corp. 2850 Frontier Drive Warsaw,  IN  46582
ContactYan Li
CorrespondentYan Li
OrthoPediatrics Corp. 2850 Frontier Drive Warsaw,  IN  46582
Product CodeHTY  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-07-02
Decision Date2021-01-29

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