VENUS LUMBAR INTERVERTEBRAL BODY FUSION CAGE SYSTEM

Intervertebral Fusion Device With Bone Graft, Lumbar

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 Lumbar Intervertebral Body Fusion Cage System.

Pre-market Notification Details

Device IDK120063
510k NumberK120063
Device Name:VENUS LUMBAR INTERVERTEBRAL BODY FUSION CAGE SYSTEM
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
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 CodeMAX  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-01-09
Decision Date2012-04-19
Summary:summary

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