FDA 510(k) Application Details - K243469

Device Classification Name	Plate, Fixation, Bone   More FDA Info for this Device
510(K) Number	K243469
Device Name	Plate, Fixation, Bone
Applicant	OSTEONIC Co., Ltd. 405Ho, 505-2Ho, 505-3Ho, 508Ho, 902Ho, 1004Ho, 1201Ho, 1202Ho, 1206Ho 38 Digital-ro 29-gil, Guro-gu Seoul 08381 KR Other 510(k) Applications for this Company
Contact	Hye-Min Ahn 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	11/08/2024
Decision Date	05/29/2025
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