Wiltrom Spinal Fixation System

Thoracolumbosacral Pedicle Screw System

Wiltrom Corporation Limited

The following data is part of a premarket notification filed by Wiltrom Corporation Limited with the FDA for Wiltrom Spinal Fixation System.

Pre-market Notification Details

Device IDK202894
510k NumberK202894
Device Name:Wiltrom Spinal Fixation System
ClassificationThoracolumbosacral Pedicle Screw System
Applicant Wiltrom Corporation Limited 1F., No. 26, Sec. 2, Shengyi Rd. Zhubei City,  TW 30261
ContactFreda Lin
CorrespondentFreda Lin
Wiltrom Corporation Limited 1F., No. 26, Sec. 2, Shengyi Rd. Zhubei City,  TW 30261
Product CodeNKB  
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-28
Decision Date2020-10-23

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