FDA 510(k) Application Details - K112028

Device Classification Name	Screw, Fixation, Bone   More FDA Info for this Device
510(K) Number	K112028
Device Name	Screw, Fixation, Bone
Applicant	GLOBUS MEDICAL, INC. 2560 GENERAL ARMISTEAD AVE. VALLEY FORGE BUSINESS CENTER AUDUBON, PA 19403 US Other 510(k) Applications for this Company
Contact	WENDY S HILLS Other 510(k) Applications for this Contact
Regulation Number	888.3040   More FDA Info for this Regulation Number
Classification Product Code	HWC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/15/2011
Decision Date	12/09/2011
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