FDA 510(k) Application Details - K180347

Device Classification Name	Intervertebral Fusion Device With Bone Graft, Lumbar   More FDA Info for this Device
510(K) Number	K180347
Device Name	Intervertebral Fusion Device With Bone Graft, Lumbar
Applicant	Fims Co., Ltd. Rm 212 Gyeonggi R&DB Center Suwon 16229 KR Suwon-si 16229 KR Other 510(k) Applications for this Company
Contact	Younggwang Choi Other 510(k) Applications for this Contact
Regulation Number	888.3080   More FDA Info for this Regulation Number
Classification Product Code	MAX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/08/2018
Decision Date	10/28/2019
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