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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Fixation, Bone
510(k) Number K250892
Device Name CastleLoc Pectus Bar 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 Kihayng 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 Kihayng Kim
Regulation Number888.3030
Classification Product Code
HRS  
Date Received03/25/2025
Decision Date 04/25/2025
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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