Cleared Traditional

ATEC IOM Accessory Instruments

K191723 · Alphatec Spine, Inc. · Neurology

Oct 2019

Decision

113d

Days

Class 2

Risk

About This 510(k) Submission

K191723 is an FDA 510(k) clearance for the ATEC IOM Accessory Instruments, a Neurosurgical Nerve Locator (Class II — Special Controls, product code PDQ), submitted by Alphatec Spine, Inc. (Carlsnad, US). The FDA issued a Cleared decision on October 18, 2019, 113 days after receiving the submission on June 27, 2019. This device falls under the Neurology review panel. Regulated under 21 CFR 874.1820.

Submission Details

510(k) Number	K191723 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 27, 2019
Decision Date	October 18, 2019
Days to Decision	113 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.