FDA 510(k) Application Details - K242247

Device Classification Name	Rod, Fixation, Intramedullary And Accessories   More FDA Info for this Device
510(K) Number	K242247
Device Name	Rod, Fixation, Intramedullary And Accessories
Applicant	Jeil Medical Corporation 702ò703ò704ò705ò706ò804ò805ò807ò812ò815-ho 55, Digital-ro 34-gil, Guro-gu Seoul 08378 KR Other 510(k) Applications for this Company
Contact	Dajung Lee 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	07/31/2024
Decision Date	04/22/2025
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