FDA 510(k) Application Details - K221578

Device Classification Name	More FDA Info for this Device
510(K) Number	K221578
Device Name	Hexanium ACIF
Applicant	SpineVision, S.A.S. 10 Rue de la Renaissance Antony 92160 FR Other 510(k) Applications for this Company
Contact	Quang Tran 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	06/01/2022
Decision Date	11/14/2022
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