FDA 510(k) Application Details - K150643

Device Classification Name	More FDA Info for this Device
510(K) Number	K150643
Device Name	Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-Ti
Applicant	CENTINEL SPINE, INC. 900 AIRPORT ROAD, SUITE 3B WEST CHESTER, PA 19380 US Other 510(k) Applications for this Company
Contact	MR. JOHN PARRY 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	03/12/2015
Decision Date	06/08/2015
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