Cleared Traditional

K152942 - NuVasiveNVM5 System

K152942 is the FDA 510(k) clearance for NuVasiveNVM5 System by Nu Vasive, Incorporated. It is a Class 2 Neurology device (product code PDQ) cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K152942 · Nu Vasive, Incorporated · Neurology device
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Jan 2016
Decision
100d
Days
Class 2
Risk

K152942 is an FDA 510(k) clearance for the NuVasiveNVM5 System. Classified as Neurosurgical Nerve Locator (product code PDQ), Class II - Special Controls.

Submitted by Nu Vasive, Incorporated (San Diego, US). The FDA issued a Cleared decision on January 13, 2016 after a review of 100 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 874.1820 - the FDA neurology 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Nu Vasive, Incorporated devices

Submission Details

510(k) Number K152942 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 2015
Decision Date January 13, 2016
Days to Decision 100 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 148d · This submission: 100d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PDQ Neurosurgical Nerve Locator
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.1820
Definition To Locate Or Monitor Function Of Spinal Nerve Roots Or Peripheral Nerves During Neurosurgery.
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 Neurology devices follow this clearance model.

Regulatory Peers - PDQ Neurosurgical Nerve Locator

All 22
Devices cleared under the same product code (PDQ) and FDA review panel - the closest regulatory comparables to K152942.
SENTIO MMG Pedicle Access Needles
K173134 · Medos International SARL · Mar 2018
ES2 Neuromonitoring Accessory Instruments
K171807 · Stryker Corporation · Jul 2017
NuVasive Next Generation NVM5 System
K162313 · Nu Vasive, Incorporated · Mar 2017
NuVasive NVM5 System
K143641 · Nu Vasive, Incorporated · Mar 2015
NUVASIVE NVM5 SYSTEM
K141968 · Nuvasive, Inc. · Nov 2014
NUVASIVE NVM5 SYSTEM
K132694 · Nu Vasive, Incorporated · May 2014