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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sacroiliac Joint Fixation
510(k) Number K153656
Device Name PathLoc-SI Joint Fusion 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 Yerim An
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 Number888.3040
Classification Product Code
OUR  
Date Received12/21/2015
Decision Date 11/14/2016
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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