FDA 510(k) Application Details - K221844

Device Classification Name	Intervertebral Fusion Device With Bone Graft, Lumbar   More FDA Info for this Device
510(K) Number	K221844
Device Name	Intervertebral Fusion Device With Bone Graft, Lumbar
Applicant	TDM Co., Ltd 69, Cheomdan Venture So-ro 37 beon-gil, Buk-gu Gwangju 61003 KR Other 510(k) Applications for this Company
Contact	Jung Wook 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	06/24/2022
Decision Date	08/17/2022
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