Skip to content

ARENAL Anterior Cervical Plate System

by Effortmed, LLC

510(k) K240935

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 NumberK240935 Date17 May 2024ClearedStatusActive

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  • Withdrawn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, 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 ARENAL Anterior Cervical Plate System is a spinal fixation appliance intended for the temporary stabilization of the anterior cervical spine (C2-T1) during the development of cervical spine fusions. It is used in cases of degenerative disc disease as defined by neck pain of discogenic origin with disc degeneration confirmed by patient evaluation.

The device is supplied non-sterile and is intended for single-use. It is regulated under FDA 510(k) clearance K240935 with product code KWQ and classification as a Class II orthopedic spinal fixation device. The system is indicated for use in the cervical spine region from C2 to T1 and is not MRI conditional unless otherwise specified in labeling.

Other devices from Effortmed, LLC

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 ARENAL Anterior Cervical Plate System used for?

    The ARENAL Anterior Cervical Plate System is intended for the temporary stabilization of the anterior cervical spine (C2-T1) during the development of cervical spine fusions, specifically in cases of degenerative disc disease confirmed by patient evaluation.

  • How is the ARENAL Anterior Cervical Plate System supplied and is it reusable?

    The device is supplied non-sterile and is intended for single-use only, meaning it should not be reprocessed or reused after initial implantation to ensure patient safety and device integrity.

  • What spinal levels does the ARENAL Anterior Cervical Plate System support?

    The system is indicated for use in the cervical spine region from C2 to T1, providing stabilization across this anatomical range during fusion procedures.

  • Is the ARENAL Anterior Cervical Plate System MRI conditional?

    The device is not MRI conditional unless otherwise specified in the labeling, so clinicians should consult the specific instructions for use before performing MRI scans on patients with this implant.