FDA 510(k) Application Details - K160313

Device Classification Name	More FDA Info for this Device
510(K) Number	K160313
Device Name	Xenco Medical Cervical Interbody System
Applicant	XENCO MEDICAL, LLC 9930 MESA RIM ROAD SAN DIEGO, CA 92121 US Other 510(k) Applications for this Company
Contact	GUSTAVO PRADO Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OVE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/05/2016
Decision Date	10/21/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review