FDA 510(k) Application Details - K132191

Device Classification Name	More FDA Info for this Device
510(K) Number	K132191
Device Name	SP-FIX SPINOUS PROCESS FIXATION PLATE
Applicant	GLOBUS MEDICAL, INC. 2560 GENERAL ARMISTEAD AVE. AUDUBON, PA 19403 US Other 510(k) Applications for this Company
Contact	CHRISTINA KICHULA Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PEK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/15/2013
Decision Date	11/22/2013
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