4CIS Chiron Spinal Fixation System

Thoracolumbosacral Pedicle Screw System

Solco Biomedical Co., Ltd.

The following data is part of a premarket notification filed by Solco Biomedical Co., Ltd. with the FDA for 4cis Chiron Spinal Fixation System.

Pre-market Notification Details

Device IDK203233
510k NumberK203233
Device Name:4CIS Chiron Spinal Fixation System
ClassificationThoracolumbosacral Pedicle Screw System
Applicant Solco Biomedical Co., Ltd. 154 Seotan-ro, Seotan-myeon Pyeongtaek,  KR 17704
ContactHee-Hoon Kim
CorrespondentSoo-Min Hong
Solco Biomedical Co., Ltd. 154 Seotan-ro, Seotan-myeon Pyeongtaek,  KR 17704
Product CodeNKB  
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-11-02
Decision Date2022-06-01

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