FDA 510(k) Application Details - K191477

Device Classification Name	More FDA Info for this Device
510(K) Number	K191477
Device Name	AEON-C Stand Alone System
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 Kyu Hur 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	06/04/2019
Decision Date	11/13/2019
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