FDA 510(k) Application Details - K203742

Device Classification Name	More FDA Info for this Device
510(K) Number	K203742
Device Name	IdentiTi ALIF Standalone Interbody System
Applicant	Alphatec Spine Inc. 5818 El Camino Real Carlsbad, CA 92008 US Other 510(k) Applications for this Company
Contact	Cynthia Dorne 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	12/22/2020
Decision Date	04/09/2021
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