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NuVasive CoRoent Small Interbody System

by Nu Vasive, Incorporated 2 variants

510(k) K150362

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 NumberK150362 Date11 Jun 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  • Withdrawn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
ODP
Device Class
Class II
Regulation
21 CFR Part 888.3080
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 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 Small Interbody System is an interbody fusion device designed for anterior cervical interbody fusion. It is indicated for use in patients with cervical disc degeneration or cervical spinal instability, including conditions resulting in radiculopathy, myelopathy, or pain at multiple contiguous levels from C2-T1.

This system is precision-machined from PEEK material to balance structural integrity with elasticity. The device is authorized via FDA 510(k) clearance and is intended for use in patients confirmed by imaging studies such as radiographs, CT, or MRI.

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Questions

AI-generated answers, 23 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 primary clinical indication for the NuVasive CoRoent Small Interbody System?

    This device is indicated for use in patients requiring anterior cervical interbody fusion. It is specifically designed to treat cervical disc degeneration or spinal instability that results in myelopathy, radiculopathy, or pain at multiple contiguous levels between C2 and T1.

  • What material is used to manufacture the CoRoent Small Interbody System?

    The system is precision-machined from PEEK material. This specific polymer is utilized to provide a balance between the necessary structural integrity required for spinal fusion and the elasticity needed for compatibility with the cervical anatomy.

  • How is the regulatory status of this device classified?

    The NuVasive CoRoent Small Interbody System is authorized via FDA 510(k) clearance. This indicates that the device has been determined to be substantially equivalent to legally marketed predicate devices under the traditional 510(k) regulatory pathway.

  • What diagnostic criteria are required before using this system?

    The device is intended for use in patients whose clinical condition has been confirmed through diagnostic imaging studies. Clinicians should utilize radiographs, CT scans, or MRI imaging to verify the presence of cervical disc degeneration or spinal instability prior to proceeding with the fusion procedure.