FDA 510(k) Application Details - K132894

Device Classification Name	More FDA Info for this Device
510(K) Number	K132894
Device Name	OPTIO-C ANTERIOR CERVICAL SYSTEM
Applicant	ZIMMER SPINE, INC. 7375 BUSH LAKE RD. MINNEAPOLIS, MN 55439 US Other 510(k) Applications for this Company
Contact	DONNA SEMLAK 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	09/16/2013
Decision Date	01/16/2014
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