Cleared Special

K062765 - MODIFICATION TO NUVASIVE NEUROVISION JJ...

K062765 is the FDA 510(k) clearance for MODIFICATION TO NUVASIVE NEUROVISION JJ... by Nuvasive, Inc.. It is a Class 2 Neurology device (product code GWF) cleared through the Special 510(k) pathway after a 117-day FDA review.

K062765 · Nuvasive, Inc. · Neurology device
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Jan 2007
Decision
117d
Days
Class 2
Risk

K062765 is an FDA 510(k) clearance for the MODIFICATION TO NUVASIVE NEUROVISION JJB SYSTEM. Classified as Stimulator, Electrical, Evoked Response (product code GWF), Class II - Special Controls.

Submitted by Nuvasive, Inc. (San Diego, US). The FDA issued a Cleared decision on January 24, 2007 after a review of 117 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1870 - the FDA neurology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Nuvasive, Inc. devices

Submission Details

510(k) Number K062765 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2006
Decision Date January 24, 2007
Days to Decision 117 days
Submission Type Special
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
31d faster than avg
Panel avg: 148d · This submission: 117d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code GWF Stimulator, Electrical, Evoked Response
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1870
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 - GWF Stimulator, Electrical, Evoked Response

All 50
Devices cleared under the same product code (GWF) and FDA review panel - the closest regulatory comparables to K062765.
NIM 3.0
K083124 · Medtronic Xomed, Inc. · Feb 2009
SEN-4100 ELECTRIC STIMULATOR
K071969 · Nihon Kohden America, Inc. · Oct 2008
NEUROVISION JJB SYSTEM
K072343 · Nuvasive, Inc. · Oct 2007
MEE-1000A NEUROMASTER
K051178 · Nihon Kohden America, Inc. · Aug 2005
MODIFICATION TO: NUVASIVE NEUROVISION JJB SYSTEM
K051384 · Nuvasive, Inc. · Jul 2005
TES-1 CONSTANT VOLTAGE ELECTRICAL STIMULATOR
K042350 · Cadwell Laboratories, Inc. · Nov 2004