FDA 510(k) Application Details - K240423

Device Classification Name	Appliance, Fixation, Spinal Intervertebral Body   More FDA Info for this Device
510(K) Number	K240423
Device Name	Appliance, Fixation, Spinal Intervertebral Body
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	Choi Jung Wook 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	02/13/2024
Decision Date	04/08/2024
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