LnK Lumbar Interbody 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 Lnk Lumbar Interbody Fusion Cage System.

Pre-market Notification Details

Device IDK151140
510k NumberK151140
Device Name:LnK Lumbar Interbody Fusion Cage System
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant L&K BIOMED Co., Ltd #201, 202 16-25, Dongbaekjungang-ro 16 Beon-gil Giheung-gu, Yongin-si,  KR 446-916
ContactYerim An
CorrespondentYerim An
L&K BIOMED Co., Ltd #201, 202 16-25, Dongbaekjungang-ro 16 Beon-gil Giheung-gu, Yongin-si,  KR 446-916
Product CodeMAX  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-04-29
Decision Date2015-08-18
Summary:summary

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