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Ebi Vuelock Anterior Cervical Plate System

by Ebi, L.P.

510(k) K023133

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 NumberK023133 Date18 Oct 2002ClearedStatusActive

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  • Withdrawn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)

Full name
Modification to Ebi Vuelock Anterior Cervical Plate System
510(k) Number
FDA Product Code
KWQ
Device Class
Class II
Regulation
21 CFR Part 888.3060
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 Ebi Vuelock Anterior Cervical Plate System is a spinal fixation device composed of titanium plates and screws. The plates incorporate a locking ring mechanism designed to secure the screws and provide temporary stabilization during spinal fusion procedures.

This system is designed to span one to four levels of the cervical spine and includes self-drilling screws. It is classified as an appliance, fixation, spinal intervertebral body and has received FDA 510(k) clearance.

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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 primary function of the Ebi Vuelock Anterior Cervical Plate System?

    This system is a spinal fixation device designed to provide temporary stabilization during spinal fusion procedures. It utilizes titanium plates and screws to support the cervical spine across one to four levels.

  • How are the screws secured within the system?

    The system incorporates a specialized locking ring mechanism within the plates. This design is intended to secure the screws in place once they are inserted, ensuring stability during the fusion process.

  • What type of screws are included with this cervical plate system?

    The Ebi Vuelock system includes self-drilling screws. These are designed to facilitate the fixation process during the surgical procedure by reducing the need for separate drilling steps.

  • What is the regulatory status of this device?

    The Ebi Vuelock Anterior Cervical Plate System has received FDA 510(k) clearance. This indicates that the device has been reviewed and found to be substantially equivalent to other legally marketed devices for the same intended use.