FDA 510(k) Application Details - K131122

Device Classification Name	More FDA Info for this Device
510(K) Number	K131122
Device Name	S128 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM
Applicant	RENOVIS SURGICAL TECHNOLOGIES, LLC 200 Homer Ave Ashland, MA 01721 US Other 510(k) Applications for this Company
Contact	Sharyn Orton, Ph.D. Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OVD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/22/2013
Decision Date	09/18/2013
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review