FDA 510(k) Application Details - K173201

Device Classification Name	More FDA Info for this Device
510(K) Number	K173201
Device Name	UNITY Sacroiliac Joint Fixation System
Applicant	Huvexel Co., Ltd 101-105 Megacenter, SK Technopark, 124, Sagimakgol-ro Jungwon-gu Seongnam-si 124 KR Other 510(k) Applications for this Company
Contact	Sung Hee-Lee Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OUR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/02/2017
Decision Date	04/26/2018
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