FDA 510(k) Application Details - K071151

Device Classification Name	Appliance, Fixation, Spinal Intervertebral Body   More FDA Info for this Device
510(K) Number	K071151
Device Name	Appliance, Fixation, Spinal Intervertebral Body
Applicant	SPINAL INSTRUMENTATION SIMPLIFICATION SYSTEMS LLC 8202 SHERMAN ROAD CHESTERLAND, OH 44026 US Other 510(k) Applications for this Company
Contact	KAREN E WARDEN 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	04/25/2007
Decision Date	11/07/2007
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