Cleared Special

K121837 - NUVASIVE BRIGADE ANTERIOR PLATE SYSTEM

K121837 is an FDA 510(k) clearance for NUVASIVE BRIGADE ANTERIOR PLATE SYSTEM, manufactured by Nuvasive, Inc.. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Special 510(k) pathway after a 24-day FDA review.

K121837 · Nuvasive, Inc. · Orthopedic device
Download Printable Device Report (PDF)
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Jul 2012
Decision
24d
Days
Class 2
Risk

K121837 is an FDA 510(k) clearance for the NUVASIVE BRIGADE ANTERIOR 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 16, 2012 after a review of 24 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

FDA 510(k) Submission Details - K121837

510(k) Number K121837 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 2012
Decision Date July 16, 2012
Days to Decision 24 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
98d faster than avg
Panel avg: 122d · This submission: 24d
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 612
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K121837.
RELIANCE ANTERIOR CERVICAL PLATE SYSTEM
K122216 · Reliance Medical Systems, LLC · Sep 2012
ORTHOFIX ACP (ANTERIOR CERVICAL PLATE SYSTEM)
K121658 · Orthofix, Inc. · Jul 2012
MEDICREA INTERNATIONAL ANTERIOR LUMBAR PLATE
K121323 · Medicrea International · Jul 2012
SLIMPLICITY SOLO ANTERIOR CERVICAL PLATE SYSTEM
K112748 · Spinal USA, LLC · Jul 2012
SPINE FRONTIER INDUS ACP SYSTEM
K121060 · Spinefrontier, Inc. · Jul 2012
UNIFY DYNAMIC ANTERIOR CERVICAL PLATE SYSTEM
K121049 · Globus Medical, Inc. · Jun 2012