Cleared Traditional

ATEC IOM Accessory Instruments

K221821 · Alphatec Spine, Inc. · Neurology

Sep 2022

Decision

92d

Days

Class 2

Risk

About This 510(k) Submission

K221821 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. (Carlsbad, US). The FDA issued a Cleared decision on September 23, 2022, 92 days after receiving the submission on June 23, 2022. This device falls under the Neurology review panel. Regulated under 21 CFR 874.1820.

Submission Details

510(k) Number	K221821 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 23, 2022
Decision Date	September 23, 2022
Days to Decision	92 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.