FDA 510(k) Application Details - K232097

Device Classification Name	More FDA Info for this Device
510(K) Number	K232097
Device Name	IdentiTi ALIF Interbody Systems
Applicant	Alphatec Spine, Inc. 1950 Camino Vida Roble Carlsbad, CA 92008 US Other 510(k) Applications for this Company
Contact	Andrew Zhang 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	07/13/2023
Decision Date	09/25/2023
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