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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 K200794
Device Name AccelFix Spinal Fixation 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  
Subsequent Product Codes
KWP   KWQ  
Date Received03/26/2020
Decision Date 10/20/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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