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NuVasive NVJJB System

by Nuvasive, Inc.

510(k) K112717

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 NumberK112717 Date13 Apr 2012ClearedStatusActive

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  • Withdrawn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
ETN
Device class
Class II
Regulation
21 CFR Part 874.1820
Advisory committee
Ear, Nose, Throat
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 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 NVJJB System is an intraoperative neurophysiological monitoring device used during spinal surgery. It consists of a patient module and a control unit with a touchscreen. The system inputs electrical stimulation to nerves via disposable probes/electrodes and monitors EMG or TcMEP responses.

The device is designed for use in conjunction with other NuVasive devices to assist in gaining controlled access to, and visualization of, the spinal nerve root, foramina, intervertebral disc, and surrounding tissues of the spine via uniportal or biportal approach, where anatomical restrictions safely permit. The system is authorized under FDA 510(k) clearance with product code ETN and regulation number 874.1820.

Other devices from Nuvasive, Inc.

See all devices from Nuvasive, Inc. →

Questions

AI-generated answers, 27 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 NVJJB System used for?

    The NuVasive NVJJB System is an intraoperative neurophysiological monitoring device used during spinal surgery to assist in gaining controlled access to spinal nerve roots, foramina, intervertebral discs, and surrounding tissues via uniportal or biportal approaches where anatomical restrictions safely permit.

  • How is the NuVasive NVJJB System supplied?

    The system consists of a patient module and a control unit with a touchscreen. It uses disposable probes/electrodes to input electrical stimulation to nerves and monitor EMG or TcMEP responses during spinal procedures.

  • What is the regulatory status of the NuVasive NVJJB System?

    The NuVasive NVJJB System is authorized under FDA 510(k) clearance with product code ETN and regulation number 874.1820, having been determined substantially equivalent to predicate devices.

  • Can the NuVasive NVJJB System be reused?

    The system includes a patient module and control unit that can be reused, but it requires disposable probes/electrodes for each procedure to ensure proper electrical stimulation and monitoring of nerve responses.