Cleared Special

K131520 - NEXUS ANTERIOR CERVICAL PLATE SYSTEM

K131520 is an FDA 510(k) clearance for NEXUS ANTERIOR CERVICAL PLATE SYSTEM, manufactured by Core-Nexus. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Special 510(k) pathway after a 44-day FDA review.

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

FDA 510(k) Submission Details - K131520

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.

KWQ Device Classification - Class 2, Special Controls

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 494
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K131520.
NUVASIVE DECADE LATERAL PLATE SYSTEM
K130868 · Nuvasive, Inc. · Aug 2013
ASPIRON ACP SYSTEM
K131200 · U&I Corporation · Aug 2013
TRINICA(R) ANTERIOR CERVICAL PLATE SYSTEM, TRINICA(R) SELECT ANTERIOR CERVICAL PLATE SYSTEM
K132012 · Zimmer Spine, Inc. · Aug 2013
PIONEER ASPECT ANTERIOR CERVICAL PLATE SYSTEM
K130427 · Pioneer Surgical Technology, Inc. · Jun 2013
ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM
K130640 · Medtronic Sofamor Danek USA, Inc. · Jun 2013
AZURE ANTERIOR CERVICAL PLATE SYSTEM
K130825 · Orthofix, Inc. · May 2013