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NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System, NuVasive CoRoent XL Interfixated System, Brigade System, Brigade Lateral System, BASE Interfixated Titanium System, Coalesce Thoracolumbar Interbody Fusion System, NuVasive Cohere Thoracolumbar Interbody System, NuVasive Modulus XLIF Interbody System, NuVasive Modulus TLIF Interbody System, NuVasive Modulus ALIF System, NuVasive Attrax Putty

by Nu Vasive, Incorporated

510(k) K203714

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK203714 Date23 Dec 2021ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
MAX
Device Class
Class II
Regulation
21 CFR Part 888.3080
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The NuVasive Thoracolumbar Interbody Systems are devices designed for intervertebral body fusion of the spine in skeletally mature patients. These systems include various components such as the NuVasive CoRoent Thoracolumbar System, NuVasive CoRoent XL Interfixated System, Brigade System, Brigade Lateral System, BASE Interfixated Titanium System, Coalesce Thoracolumbar Interbody Fusion System, NuVasive Cohere Thoracolumbar Interbody System, NuVasive Modulus XLIF Interbody System, NuVasive Modulus TLIF Interbody System, NuVasive Modulus ALIF System, and NuVasive Attrax Putty. They are intended for use with autogenous and/or allogeneic bone graft.

These systems are supplied by Nu Vasive, Incorporated and are indicated for use in the thoracolumbar region of the spine. The devices are subject to FDA 510(k) clearance with the product code MAX and decision code SESE. The systems are designed for intervertebral body fusion and are intended to be used with bone graft material. The specific sizes and configurations of each system component should be referenced according to the manufacturer's documentation.

Other devices from Nu Vasive, Incorporated

See all devices from Nu Vasive, Incorporated →

Questions

AI-generated answers, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What are NuVasive Thoracolumbar Interbody Systems used for?

    These systems are designed for intervertebral body fusion of the spine in skeletally mature patients, specifically for use in the thoracolumbar region. They are intended to be used with autogenous and/or allogeneic bone graft material to facilitate spinal fusion.

  • What components are included in the NuVasive Thoracolumbar Interbody Systems?

    The systems include various components such as the NuVasive CoRoent Thoracolumbar System, NuVasive CoRoent XL Interfixated System, Brigade System, Brigade Lateral System, BASE Interfixated Titanium System, Coalesce Thoracolumbar Interbody Fusion System, NuVasive Cohere Thoracolumbar Interbody System, NuVasive Modulus XLIF Interbody System, NuVasive Modulus TLIF Interbody System, NuVasive Modulus ALIF System, and NuVasive Attrax Putty.

  • What is the regulatory status of these systems?

    The NuVasive Thoracolumbar Interbody Systems are subject to FDA 510(k) clearance with the product code MAX and decision code SESE. They have been determined to be substantially equivalent to predicate devices for intervertebral body fusion in the thoracolumbar region of the spine.

  • How are these systems supplied and what sizes are available?

    These systems are supplied by Nu Vasive, Incorporated. The specific sizes and configurations of each system component should be referenced according to the manufacturer's documentation, as they vary depending on the particular system and clinical requirements.