FDA 510(k) Application Details - K231860

Device Classification Name	Screw, Fixation, Bone   More FDA Info for this Device
510(K) Number	K231860
Device Name	Screw, Fixation, Bone
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	888.3040   More FDA Info for this Regulation Number
Classification Product Code	HWC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/23/2023
Decision Date	01/18/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review