FDA 510(k) Application Details - K170800

Device Classification Name	More FDA Info for this Device
510(K) Number	K170800
Device Name	NuVasive LessRay with Enhanced Tracking
Applicant	NuVasive, Incorporated 7475 Lusk Boulevard San Diego, CA 92121 US Other 510(k) Applications for this Company
Contact	Manthan J. Damani 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	03/17/2017
Decision Date	08/18/2017
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