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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 K181600
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 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 Number888.3040
Classification Product Code
OUR  
Date Received06/18/2018
Decision Date 07/16/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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