Cleared Traditional

K143641 - NuVasive NVM5 System

K143641 is an FDA 510(k) clearance for NuVasive NVM5 System, manufactured by Nu Vasive, Incorporated. The device is a Class 2 Neurology device with product code PDQ cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K143641 · Nu Vasive, Incorporated · Neurology device
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Mar 2015
Decision
95d
Days
Class 2
Risk

K143641 is an FDA 510(k) clearance for the NuVasive NVM5 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 March 27, 2015 after a review of 95 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

FDA 510(k) Submission Details - K143641

510(k) Number K143641 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 2014
Decision Date March 27, 2015
Days to Decision 95 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
53d faster than avg
Panel avg: 148d · This submission: 95d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

PDQ Device Classification - Class 2, Special Controls

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 35
Devices cleared under the same product code (PDQ) and FDA review panel - the closest regulatory comparables to K143641.
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K142438 · Pioneer Surgical Technology, Inc. (Rti Surgical, Inc.) · Mar 2015
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K141968 · Nuvasive, Inc. · Nov 2014