FDA 510(k) Application Details - K182139

Device Classification Name	More FDA Info for this Device
510(K) Number	K182139
Device Name	AXTi Titanium Stand-Alone ALIF System
Applicant	Innovasis, Inc. 614 East 3900 South Salt Lake City, UT 84107 US Other 510(k) Applications for this Company
Contact	Marshall McCarty 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	08/07/2018
Decision Date	06/21/2019
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