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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 K143271
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 446-916
Applicant Contact Ki-Hyang Kim
Correspondent
L & K Biomed Co., Ltd.
#201, 202 16-25, Dongbaekjungang-Ro 16 Beon-Gil
Giheung-Gu, Yongin-Si,  KR 446-916
Correspondent Contact Yerim An
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received11/13/2014
Decision Date 07/01/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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