FDA 510(k) Application Details - K121924

Device Classification Name	More FDA Info for this Device
510(K) Number	K121924
Device Name	INTEGRA INTERSPINOUS PROCESS SYSTEM
Applicant	SEASPINE, INC. 2302 la Mirada Dr VISTA, CA 92081 US Other 510(k) Applications for this Company
Contact	NICK M CORDARO Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PEK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/02/2012
Decision Date	09/04/2013
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