FDA 510(k) Application Details - K150851

Device Classification Name	Appliance, Fixation, Spinal Interlaminal   More FDA Info for this Device
510(K) Number	K150851
Device Name	Appliance, Fixation, Spinal Interlaminal
Applicant	PRECISION SPINE, INC. 2050 EXECUTIVE DRIVE PEARL, MS 39208 US Other 510(k) Applications for this Company
Contact	Michael Dawson Other 510(k) Applications for this Contact
Regulation Number	888.3050   More FDA Info for this Regulation Number
Classification Product Code	KWP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/31/2015
Decision Date	06/04/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review