FDA 510(k) Application Details - K182195

Device Classification Name	More FDA Info for this Device
510(K) Number	K182195
Device Name	ArcoÖ-SA Lumbar Cage System
Applicant	NeuroStructures, Inc. 16 Technology Drive, Suite 165 Irvine, CA 92618 US Other 510(k) Applications for this Company
Contact	Kathleen Wong 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	08/14/2018
Decision Date	11/09/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review