FDA 510(k) Application Details - K100698

Device Classification Name	Intervertebral Fusion Device With Bone Graft, Cervical   More FDA Info for this Device
510(K) Number	K100698
Device Name	Intervertebral Fusion Device With Bone Graft, Cervical
Applicant	CARDINAL SPINE, LLC 11234 EL CAMINO REAL, SUITE 200 SAN DIEGO, CA 9213 US Other 510(k) Applications for this Company
Contact	DAVID J COLLETTE 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	03/11/2010
Decision Date	03/14/2011
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