FDA 510(k) Application Details - K200352

Device Classification Name	More FDA Info for this Device
510(K) Number	K200352
Device Name	Axis Spine Technologies ALIF
Applicant	Axis Spine Technologies Ltd Suite 204, 54-56 Victoria Street, St. Albans AL1 3HZ GB Other 510(k) Applications for this Company
Contact	Edwin Lindsay 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	02/13/2020
Decision Date	05/20/2020
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