FDA 510(k) Application Details - K110963

Device Classification Name	Appliance, Fixation, Spinal Interlaminal   More FDA Info for this Device
510(K) Number	K110963
Device Name	Appliance, Fixation, Spinal Interlaminal
Applicant	GLOBUS MEDICAL INC. 2560 GENERAL ARMISTEAD AVE. AUDUBON, PA 19403 US Other 510(k) Applications for this Company
Contact	KELLY J BAKER, PH.D Other 510(k) Applications for this Contact
Regulation Number	888.3050   More FDA Info for this Regulation Number
Classification Product Code	KWP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/06/2011
Decision Date	05/05/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review