FDA 510(k) Application Details - K230071

Device Classification Name	Rod, Fixation, Intramedullary And Accessories   More FDA Info for this Device
510(K) Number	K230071
Device Name	Rod, Fixation, Intramedullary And Accessories
Applicant	TDM CO., LTD. 69, Cheomdan venture so-ro 37 beon-gil, Buk-gu, 61003 KR Other 510(k) Applications for this Company
Contact	Jung Wook Choi Other 510(k) Applications for this Contact
Regulation Number	888.3020   More FDA Info for this Regulation Number
Classification Product Code	HSB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/10/2023
Decision Date	08/22/2024
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