LnK Posterior Cervical Fixation System And CastleLoc-S Posterior Cervical Fixation System

Posterior Cervical 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 Posterior Cervical Fixation System And Castleloc-s Posterior Cervical Fixation System.

Pre-market Notification Details

Device IDK200793
510k NumberK200793
Device Name:LnK Posterior Cervical Fixation System And CastleLoc-S Posterior Cervical Fixation System
ClassificationPosterior Cervical 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
CorrespondentMinju Choi
L&K BIOMED Co., Ltd. #201, 202 16-25, Dongbaekjungang-ro 16 Beon-gil, Giheung-gu, Yongin-si,  KR 17015
Product CodeNKG  
CFR Regulation Number888.3075 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-03-26
Decision Date2020-10-08

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