FDA 510(k) Application Details - K181600

Device Classification Name	More FDA Info for this Device
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 17015 KR Other 510(k) Applications for this Company
Contact	Jihyeon Seo Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OUR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/18/2018
Decision Date	07/16/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review