FDA 510(k) Application Details - K152942

Device Classification Name	More FDA Info for this Device
510(K) Number	K152942
Device Name	NuVasiveNVM5 System
Applicant	NUVASIVE INCORPORATED 7475 LUSK BOULEVARD SAN DIEGO, CA 92121 US Other 510(k) Applications for this Company
Contact	Olga Lewis 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	10/05/2015
Decision Date	01/13/2016
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