Cleared Traditional

NIM-SPINE

K031510 · Medtronic Xomed · Ear, Nose, Throat
Jun 2003
Decision
35d
Days
Class 2
Risk

About This 510(k) Submission

K031510 is an FDA 510(k) clearance for the NIM-SPINE, a Stimulator, Nerve (Class II — Special Controls, product code ETN), submitted by Medtronic Xomed (Jacksonville, US). The FDA issued a Cleared decision on June 18, 2003, 35 days after receiving the submission on May 14, 2003. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.1820.

Submission Details

510(k) Number K031510 FDA.gov
FDA Decision Cleared SESE
Date Received May 14, 2003
Decision Date June 18, 2003
Days to Decision 35 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF

Device Classification

Product Code ETN — Stimulator, Nerve
Device Class Class II — Special Controls
CFR Regulation 21 CFR 874.1820

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