FDA 510(k) Application Details - K110990

Device Classification Name	Appliance, Fixation, Spinal Intervertebral Body   More FDA Info for this Device
510(K) Number	K110990
Device Name	Appliance, Fixation, Spinal Intervertebral Body
Applicant	GOLD STANDARD ORTHOPEDICS LLC 3415 N. OLD FARM RD. E. WARSAW, IN 46582 US Other 510(k) Applications for this Company
Contact	JAMES RITTER Other 510(k) Applications for this Contact
Regulation Number	888.3060   More FDA Info for this Regulation Number
Classification Product Code	KWQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/08/2011
Decision Date	07/25/2011
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