FDA 510(k) Application Details - K160958

Device Classification Name	More FDA Info for this Device
510(K) Number	K160958
Device Name	Battalion Universal Spacer System
Applicant	ALPHATEC SPINE 5818 EL CAMINO REAL CARLSBAD, CA 92008 US Other 510(k) Applications for this Company
Contact	MARY FUNK Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PHM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/05/2016
Decision Date	09/08/2016
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