Cleared Special

K123045 - BRIGADE STANDALONE SYSTEM

K123045 is an FDA 510(k) clearance for BRIGADE STANDALONE SYSTEM, manufactured by Nuvasive, Inc.. The device is a Class 2 Orthopedic device with product code OVD cleared through the Special 510(k) pathway after a 197-day FDA review.

K123045 · Nuvasive, Inc. · Orthopedic device
Download Printable Device Report (PDF)
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Apr 2013
Decision
197d
Days
Class 2
Risk

K123045 is an FDA 510(k) clearance for the BRIGADE STANDALONE SYSTEM. Classified as Intervertebral Fusion Device With Integrated Fixation, Lumbar (product code OVD), Class II - Special Controls.

Submitted by Nuvasive, Inc. (San Diego, US). The FDA issued a Cleared decision on April 16, 2013 after a review of 197 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3080 - 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. 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

FDA 510(k) Submission Details - K123045

510(k) Number K123045 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 2012
Decision Date April 16, 2013
Days to Decision 197 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
75d slower than avg
Panel avg: 122d · This submission: 197d
Pathway characteristics
Modification to existing cleared device.

OVD Device Classification - Class 2, Special Controls

Product Code OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3080
Definition Intended To Stabilize Lumbar Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft With Or Without Supplemental Fixation.
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 - OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar

All 198
Devices cleared under the same product code (OVD) and FDA review panel - the closest regulatory comparables to K123045.
LANX FUSION SYSTEM
K131547 · Lanx, Inc. · Jul 2013
MECTALIF ANTERIOR
K124034 · Medacta International · May 2013
VAULT ALIF SYSTEM
K130445 · Spinal USA · Apr 2013
LANX FUSION SYSTEM- SA
K123767 · Lanx, Inc. · Mar 2013
SOLUS ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM
K123993 · Alphatec Spine, Inc. · Mar 2013
FRONTIER SADL INTERBODY FUSION DEVICE
K112700 · Frontier Medical Devices, Inc. · Nov 2012