FDA 510(k) Application Details - K182877

Device Classification Name	Intervertebral Fusion Device With Bone Graft, Lumbar   More FDA Info for this Device
510(K) Number	K182877
Device Name	Intervertebral Fusion Device With Bone Graft, Lumbar
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	888.3080   More FDA Info for this Regulation Number
Classification Product Code	MAX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/15/2018
Decision Date	05/03/2019
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