FDA 510(k) Application Details - K123993

Device Classification Name	More FDA Info for this Device
510(K) Number	K123993
Device Name	SOLUS ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM
Applicant	ALPHATEC SPINE, INC. 5818 EL CAMINO REAL CARLSBAD, CA 92008 US Other 510(k) Applications for this Company
Contact	TREVOR DENBO 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	12/26/2012
Decision Date	03/05/2013
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