FDA 510(k) Application Details - K152302

Device Classification Name	Intervertebral Fusion Device With Bone Graft, Cervical   More FDA Info for this Device
510(K) Number	K152302
Device Name	Intervertebral Fusion Device With Bone Graft, Cervical
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	888.3080   More FDA Info for this Regulation Number
Classification Product Code	ODP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/14/2015
Decision Date	09/10/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review