Cleared Traditional

SafeOp 3: Neural Informatix Systeem

K234092 · Alphatec Spine, Inc. · Neurology
Apr 2024
Decision
115d
Days
Class 2
Risk

About This 510(k) Submission

K234092 is an FDA 510(k) clearance for the SafeOp 3: Neural Informatix Systeem, 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 April 19, 2024, 115 days after receiving the submission on December 26, 2023. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1870.

Submission Details

510(k) Number K234092 FDA.gov
FDA Decision Cleared SESE
Date Received December 26, 2023
Decision Date April 19, 2024
Days to Decision 115 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

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