Pediatric Nailing Platform Femur

Rod, Fixation, Intramedullary And Accessories

OrthoPediatrics Corp.

The following data is part of a premarket notification filed by Orthopediatrics Corp. with the FDA for Pediatric Nailing Platform Femur.

Pre-market Notification Details

Device IDK220679
510k NumberK220679
Device Name:Pediatric Nailing Platform Femur
ClassificationRod, Fixation, Intramedullary And Accessories
Applicant OrthoPediatrics Corp. 2850 Frontier Drive Warsaw,  IN  46582
ContactYan Li
CorrespondentYan Li
OrthoPediatrics Corp. 2850 Frontier Drive Warsaw,  IN  46582
Product CodeHSB  
CFR Regulation Number888.3020 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-03-08
Decision Date2022-07-20

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