FDA 510(k) Application Details - K232115

Device Classification Name	Plate, Fixation, Bone   More FDA Info for this Device
510(K) Number	K232115
Device Name	Plate, Fixation, Bone
Applicant	TDM CO., LTD 69, Cheomdan Venture So-Ro 37beon-Gil Gwangju 61003 KR Other 510(k) Applications for this Company
Contact	Dave Kim Other 510(k) Applications for this Contact
Regulation Number	888.3030   More FDA Info for this Regulation Number
Classification Product Code	HRS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/14/2023
Decision Date	04/05/2024
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