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NuVasive CoRoent System

by Nuvasive, Inc. 4 variants

510(k) K141665

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 NumberK141665 Date13 Mar 2015ClearedStatusActive

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  • Withdrawn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, 24 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 CoRoent System is an implantable PEEK vertebral body replacement device used in the thoracolumbar spine (T1-L5) to replace diseased, collapsed, or unstable vertebral bodies resulting from tumor or trauma. The device provides structural support to achieve decompression of spinal cord and neural tissues.

The CoRoent No-Profile System is a standalone system indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease at one or two contiguous levels in the lumbar spine (L2 to S1). The device is supplied as a single-use system and has received FDA 510(k) clearance with the product code MAX.

Other devices from Nuvasive, Inc.

See all devices from Nuvasive, Inc. →

Questions

AI-generated answers, 24 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 is the NuVasive CoRoent System used for?

    The NuVasive CoRoent System is an implantable PEEK vertebral body replacement device used in the thoracolumbar spine (T1-L5) to replace diseased, collapsed, or unstable vertebral bodies resulting from tumor or trauma, providing structural support to achieve decompression of spinal cord and neural tissues.

  • Is the NuVasive CoRoent System reusable or single-use?

    The CoRoent No-Profile System is supplied as a single-use system, meaning it is designed for one-time use only and should not be reused on multiple patients to ensure safety and effectiveness.

  • What spinal levels does the NuVasive CoRoent System treat?

    The device is indicated for use in the thoracolumbar spine (T1-L5) to replace diseased vertebral bodies, and the CoRoent No-Profile System is specifically indicated for spinal fusion procedures at one or two contiguous levels in the lumbar spine (L2 to S1) in skeletally mature patients with degenerative disc disease.

  • What regulatory approvals has the NuVasive CoRoent System received?

    The NuVasive CoRoent System has received FDA 510(k) clearance with the product code MAX, which means it has been determined to be substantially equivalent to predicate devices already on the market for its intended use.