ORTHOPEDIATRICS PEDIFLEX FLEXIBLE NAIL SYSTEM

Pin, Fixation, Smooth

ORTHOPEDIATRICS, LLC

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

Pre-market Notification Details

Device IDK081097
510k NumberK081097
Device Name:ORTHOPEDIATRICS PEDIFLEX FLEXIBLE NAIL SYSTEM
ClassificationPin, Fixation, Smooth
Applicant ORTHOPEDIATRICS, LLC 210 NORTH BUFFALO STREET Warsaw,  IN  46580
ContactGary Barnett
CorrespondentGary Barnett
ORTHOPEDIATRICS, LLC 210 NORTH BUFFALO STREET Warsaw,  IN  46580
Product CodeHTY  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-04-17
Decision Date2008-06-03
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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00841132145463 K081097 000

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