FDA 510(k) Application Details - K191723

Device Classification Name	More FDA Info for this Device
510(K) Number	K191723
Device Name	ATEC IOM Accessory Instruments
Applicant	Alphatec Spine, Inc. 5818 El Camino Real Carlsbad, CA 92008 US Other 510(k) Applications for this Company
Contact	Ruby Zheng Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PDQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/27/2019
Decision Date	10/18/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review