Cleared Traditional

K031510 - NIM-SPINE

K031510 is the FDA 510(k) clearance for NIM-SPINE by Medtronic Xomed. It is a Class 2 Ear, Nose, Throat device (product code ETN) cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K031510 · Medtronic Xomed · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2003
Decision
35d
Days
Class 2
Risk

K031510 is an FDA 510(k) clearance for the NIM-SPINE. Classified as Stimulator, Nerve (product code ETN), Class II - Special Controls.

Submitted by Medtronic Xomed (Jacksonville, US). The FDA issued a Cleared decision on June 18, 2003 after a review of 35 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.1820 - the FDA ear, nose and throat device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Medtronic Xomed devices

Submission Details

510(k) Number K031510 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 89d · This submission: 35d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

Product Code ETN Stimulator, Nerve
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.1820
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ear, Nose, Throat devices follow this clearance model.

Regulatory Peers - ETN Stimulator, Nerve

All 38
Devices cleared under the same product code (ETN) and FDA review panel - the closest regulatory comparables to K031510.
CONTACT EMG ROTATABLE ENDOTRACHEAL TUBE
K050162 · Medtronic Xomed, Inc. · Mar 2005
NUVASIVE NEUROVISION JJB SYSTEM
K040543 · Nuvasive, Inc. · Apr 2004
NUVASIVE NEUROVISION JJB SYSTEM
K032083 · Nuvasive, Inc. · Oct 2003
STIMULUS/DISSECTION INSTRUMENTS, BALL-TIP PROBES
K031003 · Medtronic Xomed, Inc. · Apr 2003
STIMULUS - DISSECTION INSTRUMENTS
K014165 · Medtronic Xomed, Inc. · Jan 2002
XOMED BALL-TIP MONOPOLAR STIMULATOR PROBE
K992869 · Xomed, Inc. · Oct 1999