FDA 510(k) Application Details - K152747

Device Classification Name	More FDA Info for this Device
510(K) Number	K152747
Device Name	DSG Threaded Drill System
Applicant	SPINEGUARD, S.A. 10 COURS LOUIS LUMIERE VINCENNES 94300 FR Other 510(k) Applications for this Company
Contact	STEPHANE BETTE 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	09/23/2015
Decision Date	06/10/2016
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