MEGAFIX® Pedicle Screw Spinal System

Thoracolumbosacral Pedicle Screw System

SeohanCare Co., Ltd

The following data is part of a premarket notification filed by Seohancare Co., Ltd with the FDA for Megafix® Pedicle Screw Spinal System.

Pre-market Notification Details

Device IDK191655
510k NumberK191655
Device Name:MEGAFIX® Pedicle Screw Spinal System
ClassificationThoracolumbosacral Pedicle Screw System
Applicant SeohanCare Co., Ltd 2F Da-dong 22, Gimpo-daero 2918beon-gil, Wolgot-myeon Gimpo-si,  KR 10020
ContactChae Lynn Song
CorrespondentMeredith May
Empirical Testing Corp. 4628 Northpark Drive Colorado Springs,  CO  80918
Product CodeNKB  
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyOrthopedic
510k Review PanelOrthopedic
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-06-21
Decision Date2020-03-06

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