FDA 510(k) Application Details - K083389

Device Classification Name	More FDA Info for this Device
510(K) Number	K083389
Device Name	COALITION SPACER
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	OVE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/17/2008
Decision Date	03/26/2009
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