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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Spinal Intervertebral Body
510(k) Number K190425
Device Name CastleLoc-P Anterior Cervical Plate System
Applicant
L & K Biomed Co., Ltd.
#201, #202 16-25, Dongbaekjungang-Ro 16 Beon-Gil
Giheung-Gu
Yongin-Si,  KR 17015
Applicant Contact Jihyeon Seo
Correspondent
L & K Biomed Co., Ltd.
#201, #202 16-25, Dongbaekjungang-Ro 16 Beon-Gil
Giheung-Gu
Yongin-Si,  KR 17015
Correspondent Contact Jihyeon Seo
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received02/22/2019
Decision Date 03/21/2019
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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