FDA 510(k) Application Details - K251431

Device Classification Name	More FDA Info for this Device
510(K) Number	K251431
Device Name	FIX-C PEEK ACIF SA System
Applicant	Jeil Medical Corporation 702ò703ò704ò705ò706ò707ò804ò805ò807ò812ò815-ho 55, Digital-ro 34-gil, Guro-gu Seoul 08378 KR Other 510(k) Applications for this Company
Contact	Jinwoo Kim Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OVE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/08/2025
Decision Date	06/27/2025
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