FDA 510(k) Application Details - K122771

Device Classification Name	More FDA Info for this Device
510(K) Number	K122771
Device Name	SPINAL ELEMENTS CERVICAL INTERVERTEBRAL BODY FUSION SYSTEM
Applicant	SPINAL ELEMENTS, INC. 2744 LOKER AVE. W. SUITE 100 CARLSBAD, CA 92010 US Other 510(k) Applications for this Company
Contact	BENJAMIN A KIMBALL 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	09/10/2012
Decision Date	01/10/2013
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