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Lanx Anterior Cervial Plate System

by Lanx, LLC

510(k) K040401

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 NumberK040401 Date12 Apr 2004ClearedStatusActive

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  • Withdrawn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
KWQ
Device Class
Class II
Regulation
21 CFR Part 888.3060
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 Lanx Anterior Cervical Plate System is an orthopedic device. It is a type of plate system used in medical procedures.

The device is supplied by Lanx, LLC and has been found to be substantially equivalent. It has an FDA 510K authorization and is classified under product code KWQ. The system is used in orthopedic applications.

Other devices from Lanx, Inc.

See all devices from Lanx, Inc. →

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 Lanx Anterior Cervical Plate System used for?

    The Lanx Anterior Cervical Plate System is used in orthopedic applications, specifically in medical procedures involving the cervical spine.

  • Is the Lanx Anterior Cervical Plate System sterile?

    The device data does not specify the sterility of the Lanx Anterior Cervical Plate System, it is recommended to consult the manufacturer or packaging for this information.

  • What is the regulatory status of the Lanx Anterior Cervical Plate System?

    The Lanx Anterior Cervical Plate System has an FDA 510K authorization, indicating it has been found to be substantially equivalent to a predicate device.