FDA 510(k) Application Details - K142095

Device Classification Name	More FDA Info for this Device
510(K) Number	K142095
Device Name	RENOVIS S134 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM
Applicant	Renovis Surgical Technologies, Inc. 200 HOMER AVE. ASHLAND, MA 01721 US Other 510(k) Applications for this Company
Contact	Sharyn Orton 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	08/01/2014
Decision Date	10/15/2014
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