Cleared Traditional

K181386 - NuVasive Brigade Lateral System

K181386 is the FDA 510(k) clearance for NuVasive Brigade Lateral System by Nu Vasive, Incorporated. It is a Class 2 Orthopedic device (product code OVD) cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K181386 · Nu Vasive, Incorporated · Orthopedic device
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Aug 2018
Decision
91d
Days
Class 2
Risk

K181386 is an FDA 510(k) clearance for the NuVasive Brigade Lateral System. Classified as Intervertebral Fusion Device With Integrated Fixation, Lumbar (product code OVD), Class II - Special Controls.

Submitted by Nu Vasive, Incorporated (San Diego, US). The FDA issued a Cleared decision on August 24, 2018 after a review of 91 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3080 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Nu Vasive, Incorporated devices

Submission Details

510(k) Number K181386 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 25, 2018
Decision Date August 24, 2018
Days to Decision 91 days
Submission Type Traditional
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
31d faster than avg
Panel avg: 122d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 147
Devices cleared under the same product code (OVD) and FDA review panel - the closest regulatory comparables to K181386.
Arco™-SA Lumbar Cage System
K182195 · Neurostructures, Inc. · Nov 2018
Scarlet AL-T
K181818 · Spineart · Oct 2018
DYNA-LINK ELITE Stand-Alone Anterior Lumbar System
K180215 · Life Spine, Inc. · Sep 2018
CoreLink® M3™ Stand-Alone Anterior Lumbar System
K180814 · Corelink, LLC · Aug 2018
FBC 921 (ALIF)
K180695 · Fbc Device Aps · Jul 2018
S128 Anterior Lumbar Interbody Fusion (ALIF) System
K180502 · Renovis Surgical Technologies, Inc. · Jun 2018