FDA 510(k) Application Details - K120177

Device Classification Name	Cerclage, Fixation   More FDA Info for this Device
510(K) Number	K120177
Device Name	Cerclage, Fixation
Applicant	SPINAL ELEMENTS, INC. 2744 LOKER AVE. W. SUITE 100 CARLSBAD, CA 92008 US Other 510(k) Applications for this Company
Contact	BENJAMIN A KIMBALL Other 510(k) Applications for this Contact
Regulation Number	888.3010   More FDA Info for this Regulation Number
Classification Product Code	JDQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/20/2012
Decision Date	07/03/2012
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