FDA 510(k) Application Details - K102402

Device Classification Name	More FDA Info for this Device
510(K) Number	K102402
Device Name	SOLUS ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SPINAL SPACER SYSTEM
Applicant	ALPHATEC SPINE, INC. 5818 EL CAMINO REAL CARLSBAD, CA 92008 US Other 510(k) Applications for this Company
Contact	MARY STANNERS 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	08/24/2010
Decision Date	03/30/2011
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