FDA 510(k) Application Details - K240201

Device Classification Name	More FDA Info for this Device
510(K) Number	K240201
Device Name	PathLoc SI Joint Fusion System
Applicant	L&K Biomed Co., Ltd. #101, 201, 202 16-25, Dongbaekjungang-ro 16 beon-gil Giheung-gu Yongin-si 17015 KR Other 510(k) Applications for this Company
Contact	Kihyang Kim 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	01/25/2024
Decision Date	02/23/2024
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