LumFix Spinal Fixation Sytem

Orthosis, Spinal Pedicle Fixation

CG BIO CO., LTD.

The following data is part of a premarket notification filed by Cg Bio Co., Ltd. with the FDA for Lumfix Spinal Fixation Sytem.

Pre-market Notification Details

Device IDK160731
510k NumberK160731
Device Name:LumFix Spinal Fixation Sytem
ClassificationOrthosis, Spinal Pedicle Fixation
Applicant CG BIO CO., LTD. 244, GALMACHI-RO, JUNGWON-GU Seongnam-si,  KR 13211
ContactYuna Jeong
CorrespondentApril Lee
WITHUS GROUP INC 2531 PEPPERDALE DRIVE Rowland Heights,  CA  91748
Product CodeMNI  
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-03-17
Decision Date2016-10-04
Summary:summary

NIH GUDID Devices

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