Cleared Traditional

SafeOp 3: Neural Informatix System

K252842 · Alphatec Spine, Inc. · Neurology
Jan 2026
Decision
125d
Days
Class 2
Risk

About This 510(k) Submission

K252842 is an FDA 510(k) clearance for the SafeOp 3: Neural Informatix System, a Stimulator, Electrical, Evoked Response (Class II — Special Controls, product code GWF), submitted by Alphatec Spine, Inc. (Carlsbad, US). The FDA issued a Cleared decision on January 11, 2026, 125 days after receiving the submission on September 8, 2025. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1870.

Submission Details

510(k) Number K252842 FDA.gov
FDA Decision Cleared SESE
Date Received September 08, 2025
Decision Date January 11, 2026
Days to Decision 125 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code GWF — Stimulator, Electrical, Evoked Response
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.1870

Similar Devices — GWF Stimulator, Electrical, Evoked Response

All 138
Nicolet EDX
K243982 · Natus Neurology Incorporated · Jan 2025
Natus Ultrapro S100 (982A0594)
K243495 · Natus Neurology Incorporated · Dec 2024
Delphi Stimulator
K242345 · Quantalx Neuroscience · Nov 2024
SafeOp 3: Neural Informatix Systeem
K234092 · Alphatec Spine, Inc. · Apr 2024
MEGA-IOM system with Neuro-IOM.NET software (32/B - 32/S - 16/S)
K234080 · Soterix Medical, Inc. · Mar 2024
ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress
K233292 · Inomed Medizintechnik GmbH · Oct 2023