FDA 510(k) Application Details - K231808

Device Classification Name	More FDA Info for this Device
510(K) Number	K231808
Device Name	QUASAR Standalone ACIF System
Applicant	GS Medical Co. Ltd. 90, Osongsaengmyeong 4-ro, Osong-eup Heungdeok-gu Cheongju-si 28161 KR Other 510(k) Applications for this Company
Contact	Seon Yeon 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	06/20/2023
Decision Date	07/20/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review