FDA 510(k) Application Details - K240199

Device Classification Name	More FDA Info for this Device
510(K) Number	K240199
Device Name	IntraOp Alignment System
Applicant	Alphatec Spine, Inc. 1950 Camino Vida Roble Carlsbad, CA 92008 US Other 510(k) Applications for this Company
Contact	Unnati Bhuptani Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OWB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/25/2024
Decision Date	05/22/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review