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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name thoracolumbosacral pedicle screw system
510(k) Number K200789
Device Name LnK MIS Spinal System, PathLoc-L MIS Spinal System, AccelFix-MIS Spinal System
Applicant
L&K BIOMED Co., Ltd.
#201, #202 16-25, Dongbaekjungang-ro 16 beon-gil
Giheung-gu
Yongin-si,  KR 17015
Applicant Contact KiHyang Kim
Correspondent
L&K BIOMED Co., Ltd.
#201, #202 16-25, Dongbaekjungang-ro 16 beon-gil
Giheung-gu
Yongin-si,  KR 17015
Correspondent Contact Minju Choi
Regulation Number888.3070
Classification Product Code
NKB  
Date Received03/26/2020
Decision Date 12/04/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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