FDA 510(k) Application Details - K171413

Device Classification Name	Orthosis, Spine, Plate, Laminoplasty, Metal   More FDA Info for this Device
510(K) Number	K171413
Device Name	Orthosis, Spine, Plate, Laminoplasty, Metal
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	888.3050   More FDA Info for this Regulation Number
Classification Product Code	NQW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/15/2017
Decision Date	07/14/2017
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