LnK Spinal Fixation System, OpenLoc-L 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 Lnk Spinal Fixation System, Openloc-l Spinal Fixation System.

Pre-market Notification Details

Device IDK200790
510k NumberK200790
Device Name:LnK Spinal Fixation System, OpenLoc-L Spinal Fixation System
ClassificationThoracolumbosacral Pedicle Screw System
Applicant L&K BIOMED Co., Ltd. #201, 202 16-25, Dongbaekjungang-ro 16 Beon-gil, Giheung-gu Yongin-si,  KR 17015
ContactKihyang Kim
CorrespondentKihyang Kim
L&K BIOMED Co., Ltd. #201, 202 16-25, Dongbaekjungang-ro 16 Beon-gil, Giheung-gu Yongin-si,  KR 17015
Product CodeNKB  
Subsequent Product CodeKWP
Subsequent Product CodeKWQ
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-03-26
Decision Date2020-10-28

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.