FDA 510(k) Application Details - K153446

Device Classification Name	More FDA Info for this Device
510(K) Number	K153446
Device Name	OLYMPIC Posterior Spinal Fixation System
Applicant	Astura Medical 5670 El Camino Real, Suite B Carlsbad, CA 92008 US Other 510(k) Applications for this Company
Contact	Troy Taylor Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OSH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/27/2015
Decision Date	04/08/2016
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