FDA 510(k) Application Details - K182007

Device Classification Name	More FDA Info for this Device
510(K) Number	K182007
Device Name	Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) System
Applicant	Renovis Surgical Technologies 1901 W. Lugonia Ave., Suite 340 Redlands, CA 92374 US Other 510(k) Applications for this Company
Contact	Anthony DeBenedictis 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	07/27/2018
Decision Date	12/07/2018
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