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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 K232311
Device Name LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System
Applicant
L&K BIOMED Co., Ltd.
#101, 201, 202 16-25, Dongbaekjungang-Ro 16 Beon-Gil Giheung
Yongin-Si,  KR 17015
Applicant Contact Katherine Kim
Correspondent
L&K BIOMED Co., Ltd.
#101, 201, 202 16-25, Dongbaekjungang-Ro 16 Beon-Gil Giheung
Yongin-Si,  KR 17015
Correspondent Contact Katherine Kim
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   KWQ  
Date Received08/02/2023
Decision Date 08/14/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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