ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages)

by Arftx Medical, LLC

510(k) K211892

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

510(k) K211892↗

FDA record

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

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK211892	Date6 Oct 2022Cleared	StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K211892
FDA Product Code: MQP

Device Class: Class II
Regulation: 21 CFR Part 888.3060
Advisory Committee: Orthopedic
FDA Decision: SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages) are spinal vertebral body replacement devices intended to restore the integrity of the spinal column. They are used in patients with advanced stage tumors involving the cervical, thoracic, and lumbar spine where life expectancy is insufficient to permit achievement of fusion.

These devices are supplied as implantable spinal cages and are classified as Class II medical devices under product code MQP. They received FDA 510(k) clearance (K211892) as substantially equivalent to a predicate device and are subject to special controls. The device is intended for limited-time use in spinal stabilization without fusion.