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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Posterior Cervical Screw System
510(k) Number K231840
Device Name CastleLoc-S Posterior Cervical Fixation System
Applicant
L & K Biomed Co., Ltd.
#101, 201, 202 16-25, Dongbaekjungang-Ro 16 Beon-Gil
Giheung-Gu,
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-Gu,
Yongin-Si,  KR 17015
Correspondent Contact Katherine Kim
Regulation Number888.3075
Classification Product Code
NKG  
Subsequent Product Code
KWP  
Date Received06/22/2023
Decision Date 07/20/2023
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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