CastleLoc-S Posterior Cervical Fixation System; LnK 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 Castleloc-s Posterior Cervical Fixation System; Lnk Posterior Cervical Fixation System.

Pre-market Notification Details

Device IDK162136
510k NumberK162136
Device Name:CastleLoc-S Posterior Cervical Fixation System; LnK 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 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 CodeNKG  
CFR Regulation Number888.3075 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-08-01
Decision Date2016-11-03
Summary:summary

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