Cleared Special

K111866 - NUVASIVE ANTERIOR LUMBAR PLATE SYSTEM

K111866 is the FDA 510(k) clearance for NUVASIVE ANTERIOR LUMBAR PLATE SYSTEM by Nuvasive, Inc.. It is a Class 2 Orthopedic device (product code KWQ) cleared through the Special 510(k) pathway after a 22-day FDA review.

K111866 · Nuvasive, Inc. · Orthopedic device
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Jul 2011
Decision
22d
Days
Class 2
Risk

K111866 is an FDA 510(k) clearance for the NUVASIVE ANTERIOR LUMBAR PLATE SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Nuvasive, Inc. (San Diego, US). The FDA issued a Cleared decision on July 22, 2011 after a review of 22 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 Nuvasive, Inc. devices

Submission Details

510(k) Number K111866 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 2011
Decision Date July 22, 2011
Days to Decision 22 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
100d faster than avg
Panel avg: 122d · This submission: 22d
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 438
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K111866.
DEPUY PULSE ANTERIOR CERICAL PLATE SYSTEM
K112724 · Medos International SARL · Nov 2011
INVIZIA ANTERIOR CERVICAL PLATE SYSTEM
K111796 · Zimmer Spine, Inc. · Oct 2011
PYRENEES CERVICAL PLATE SYSTEM (TRANSLATIONAL PLATES)
K111135 · K2m, Inc. · Aug 2011
NUVASIVE LONG LATERAL SPINAL SYSTEM
K111410 · Nuvasive, Inc. · Jun 2011
MIS ANTERIOR CERVICAL PLATING SYSTEM
K103423 · Life Spine · Jun 2011
NUVASIVE TRAVERSE PLATE SYSTEM
K103750 · Nuvasive, Inc. · Mar 2011