Cleared Traditional

DSG Threaded Drill System

K152747 · Spineguard S.A. · Neurology

Jun 2016

Decision

261d

Days

Class 2

Risk

About This 510(k) Submission

K152747 is an FDA 510(k) clearance for the DSG Threaded Drill System, a Neurosurgical Nerve Locator (Class II — Special Controls, product code PDQ), submitted by Spineguard S.A. (Vincennes, FR). The FDA issued a Cleared decision on June 10, 2016, 261 days after receiving the submission on September 23, 2015. This device falls under the Neurology review panel. Regulated under 21 CFR 874.1820.

Submission Details

510(k) Number	K152747 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 23, 2015
Decision Date	June 10, 2016
Days to Decision	261 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF

Device Classification

Product Code	PDQ — Neurosurgical Nerve Locator
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 874.1820
Definition	To Locate Or Monitor Function Of Spinal Nerve Roots Or Peripheral Nerves During Neurosurgery.