FDA 510(k) Application Details - K193000

Device Classification Name	More FDA Info for this Device
510(K) Number	K193000
Device Name	Hexanium« ACIF
Applicant	SpineVision SAS 10 rue de la Renaissance Batiment E Antony 92160 FR Other 510(k) Applications for this Company
Contact	Anaelle Gallego 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	10/28/2019
Decision Date	10/20/2020
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