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NuVasive Modulus-C Interbody System

by Nuvasive, Inc.

510(k) K223731

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 · Special NumberK223731 Date12 Jan 2023ClearedStatusActive

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  • Withdrawn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, 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 Modulus-C Interbody System is an orthopedic device indicated for intervertebral body fusion of the spine in skeletally mature patients. It is intended for use in anterior cervical interbody fusion for patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies such as radiographs, CT, or MRI, which may present with radiculopathy or myelopathy.

The device is supplied as part of a spinal fusion system and has received FDA 510(k) clearance under K223731, determined to be substantially equivalent to a predicate device. It is manufactured by Nuvasive, Inc. and is intended for use in surgical settings by trained healthcare professionals. No information regarding sterility, single-use or reusable status, MRI safety, specific sizes, storage conditions, or additional authorisations is provided in the supplied data.

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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 is the NuVasive Modulus-C Interbody System used for?

    It is indicated for intervertebral body fusion of the spine in skeletally mature patients, specifically for anterior cervical interbody fusion in cases of cervical disc degeneration and/or cervical spinal instability confirmed by imaging such as radiographs, CT, or MRI, which may present with radiculopathy or myelopathy.

  • Who manufactures the NuVasive Modulus-C Interbody System and where are they located?

    The device is manufactured by Nuvasive, Inc., located at 7475 Lusk Blvd., San Diego, CA 92121, United States, as indicated in the device authorization data.

  • What regulatory pathway was used for the NuVasive Modulus-C Interbody System?

    The device received FDA 510(k) clearance under K223731, determined to be substantially equivalent to a predicate device, with a decision date of January 12, 2023, following submission on December 13, 2022.