FDA 510(k) Application Details - K132596

Device Classification Name	More FDA Info for this Device
510(K) Number	K132596
Device Name	PROPOSED OPTIMUS
Applicant	CUSTOM SPINE, INC. 9 Campus Dr PARSIPPANY, NJ 07054 US Other 510(k) Applications for this Company
Contact	HANAA SHAHIN Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OVD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/19/2013
Decision Date	04/11/2014
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