FDA 510(k) Application Details - K172269

Device Classification Name	More FDA Info for this Device
510(K) Number	K172269
Device Name	FORTRESSÖ Radiopaque Bone Cement (FORTRESSÖ and FORTRESS-PlusÖ), CREO« Fenestrated Screw System, REVLOK« Fenestrated Screw System
Applicant	Globus Medical, Inc. 2560 General Armistead Ave. Audubon, PA 19403 US Other 510(k) Applications for this Company
Contact	Kelly J. Baker Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PML Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/28/2017
Decision Date	03/27/2018
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