ORTHOPEDIATRICS PEDIPLATES SYSTEM

Plate, Fixation, Bone

ORTHOPEDIATRICS, CORP.

The following data is part of a premarket notification filed by Orthopediatrics, Corp. with the FDA for Orthopediatrics Pediplates System.

Pre-market Notification Details

Device IDK081407
510k NumberK081407
Device Name:ORTHOPEDIATRICS PEDIPLATES SYSTEM
ClassificationPlate, Fixation, Bone
Applicant ORTHOPEDIATRICS, CORP. 210 N. BUFFALO ST. Warsaw,  IN  46580
ContactGary Barnett
CorrespondentGary Barnett
ORTHOPEDIATRICS, CORP. 210 N. BUFFALO ST. Warsaw,  IN  46580
Product CodeHRS  
Subsequent Product CodeHWC
Subsequent Product CodeOBT
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-05-19
Decision Date2008-07-22
Summary:summary

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