FDA 510(k) Application Details - K183119

Device Classification Name	More FDA Info for this Device
510(K) Number	K183119
Device Name	SI-LOK« Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS« Instruments
Applicant	Globus Medical Inc. Valley Forge Business Center 2560 General Armistead Ave. Audubon, PA 19403 US Other 510(k) Applications for this Company
Contact	Lori Burns Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OUR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/09/2018
Decision Date	02/06/2019
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