VENUS SPINAL FIXATION SYSTEM

Thoracolumbosacral Pedicle Screw System

L&K BIOMED CO., LTD

The following data is part of a premarket notification filed by L&k Biomed Co., Ltd with the FDA for Venus Spinal Fixation System.

Pre-market Notification Details

Device IDK120270
510k NumberK120270
Device Name:VENUS SPINAL FIXATION SYSTEM
ClassificationThoracolumbosacral Pedicle Screw System
Applicant L&K BIOMED CO., LTD #1104, ACE HIGH-END TOWER 3 CHA, 371-50 GASAN-DONG Geumcheon-gu, Seoul,  KR 153-803
ContactHee Kyeong Joo
CorrespondentHee Kyeong Joo
L&K BIOMED CO., LTD #1104, ACE HIGH-END TOWER 3 CHA, 371-50 GASAN-DONG Geumcheon-gu, Seoul,  KR 153-803
Product CodeNKB  
Subsequent Product CodeKWP
Subsequent Product CodeKWQ
Subsequent Product CodeMNH
Subsequent Product CodeMNI
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-01-30
Decision Date2012-03-26
Summary:summary

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