FDA 510(k) Application Details - K192492

Device Classification Name	More FDA Info for this Device
510(K) Number	K192492
Device Name	EL CAPITAN Anterior Lumber Interbody System
Applicant	Astura Medical, LLC 3186 Lionshead Ave, Suite 100 Carlsbad, CA 92010 US Other 510(k) Applications for this Company
Contact	Parker Kelch Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OVD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/11/2019
Decision Date	04/21/2020
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