FDA 510(k) Application Details - K214047

Device Classification Name	More FDA Info for this Device
510(K) Number	K214047
Device Name	EL CAPITAN Anterior Lumbar Interbody Fusion System
Applicant	Astura Medical 4949 W Royal Ln. Irving, TX 75063 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	12/27/2021
Decision Date	03/30/2022
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