FDA 510(k) Application Details - K234119

Device Classification Name	More FDA Info for this Device
510(K) Number	K234119
Device Name	UniSpace« Stand-Alone C Cage
Applicant	Innosys Co., Ltd. 20, Sandan-ro 76beon-gil(Rd) Uijeongbu-si 11781 KR Other 510(k) Applications for this Company
Contact	Chae-Hyeon 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	12/28/2023
Decision Date	04/19/2024
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