FDA 510(k) Application Details - K163670

Device Classification Name	More FDA Info for this Device
510(K) Number	K163670
Device Name	Rampart One Lumbar Interbody Fusion Device
Applicant	SPINEOLOGY INC. 7800 3RD STREET N., SUITE 600 ST. PAUL, MN 55128 US Other 510(k) Applications for this Company
Contact	Jacqueline A. Hauge 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	12/27/2016
Decision Date	05/08/2017
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