FDA 510(k) Application Details - K160352

Device Classification Name	More FDA Info for this Device
510(K) Number	K160352
Device Name	MAGEC« Spinal Bracing and Distraction System
Applicant	NuVasive Specialized Orthopedics, Inc. 101 ENTERPRISE SUITE 100 ALISO VIEJO, CA 92656 US Other 510(k) Applications for this Company
Contact	LANCE JUSTICE Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PGN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/08/2016
Decision Date	10/21/2016
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