FDA 510(k) Application Details - K151198

Device Classification Name	More FDA Info for this Device
510(K) Number	K151198
Device Name	A-CIFT SoloFuse
Applicant	SPINEFRONTIER, INC. 500 CUMMINGS CENTER, STE 3500 BEVERLY, MA 01915 US Other 510(k) Applications for this Company
Contact	MANTHAN J DAMANI 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	05/05/2015
Decision Date	07/17/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review