FDA 510(k) Application Details - K113796

Device Classification Name	More FDA Info for this Device
510(K) Number	K113796
Device Name	SOLITAIRE-C CERVICAL SPACER SYSTEM
Applicant	EBI, LLC 399 Jefferson Rd PARSIPPANY, NJ 07054 US Other 510(k) Applications for this Company
Contact	MARGARET CROWE 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	12/23/2011
Decision Date	04/26/2012
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