FDA 510(k) Application Details - K180729

Device Classification Name	System, Facet Screw Spinal Device   More FDA Info for this Device
510(K) Number	K180729
Device Name	System, Facet Screw Spinal Device
Applicant	Huvexel Co., Ltd 101-105 Megacenter, SKn Technopark, 124, Sagimakgol-ro Jungwon-gu Seongnam-si 13207 KR Other 510(k) Applications for this Company
Contact	Sung Hee-Lee Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	MRW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/20/2018
Decision Date	06/28/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review