FDA 510(k) Application Details - K192481

Device Classification Name	Appliance, Fixation, Spinal Intervertebral Body   More FDA Info for this Device
510(K) Number	K192481
Device Name	Appliance, Fixation, Spinal Intervertebral Body
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	KiHyang Kim Other 510(k) Applications for this Contact
Regulation Number	888.3060   More FDA Info for this Regulation Number
Classification Product Code	KWQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/10/2019
Decision Date	07/28/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review