FDA 510(k) Application Details - K173117

Device Classification Name	More FDA Info for this Device
510(K) Number	K173117
Device Name	NuVasive« VersaTieÖ System
Applicant	NuVasive, Inc. 7475 Lusk Blvd San Diego, CA 92121 US Other 510(k) Applications for this Company
Contact	Marysa Loustalot Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OWI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/29/2017
Decision Date	12/07/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review