Cleared Special

NEXUS ANTERIOR CERVICAL PLATE SYSTEM (K131520) - FDA 510(k) Clearance

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K131520 · Core-Nexus · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2013
Decision
44d
Days
Class 2
Risk

K131520 is an FDA 510(k) clearance for the NEXUS ANTERIOR CERVICAL PLATE SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Core-Nexus (Encino, US). The FDA issued a Cleared decision on July 11, 2013 after a review of 44 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3060 - the FDA orthopedic device regulatory 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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Core-Nexus devices

Submission Details

510(k) Number K131520 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 2013
Decision Date July 11, 2013
Days to Decision 44 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 122d · This submission: 44d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code KWQ Appliance, Fixation, Spinal Intervertebral Body
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3060
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 Orthopedic devices follow this clearance model.

Regulatory Peers - KWQ Appliance, Fixation, Spinal Intervertebral Body

All 224
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K131520.
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K143576 · Exactech, Inc. · Feb 2015
ZEVO (TM) ANTERIOR CERVICAL PLATE SYSTEM
K141632 · Medtronic Sofamor Danek USA, Inc. · Dec 2014
UNIFY(R) DYNAMIC ANTERIOR CERVICAL PLATE SYSTEM
K133567 · Globus Medical, Inc. · Feb 2014
ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM
K130640 · Medtronic Sofamor Danek USA, Inc. · Jun 2013
UNIFY DYNAMIC ANTERIOR CERVICAL PLATE SYSTEM
K121049 · Globus Medical, Inc. · Jun 2012
PLYMOUTH THORACOLUMBAR PLATE SYSTEM
K120092 · Globus Medical, Inc. · Apr 2012