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CONDUIT Lateral Switch Plate

by Medos International SARL

510(k) K221325

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K221325↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, 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 510(k) Substantially Equivalent · Traditional NumberK221325 Date25 Aug 2022ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

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

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
MAX
Device Class
Class II
Regulation
21 CFR Part 888.3080
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 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 Conduit Lateral Switch Plate is an Intervertebral Fusion Device With Bone Graft, Lumbar (product code MAX), designed to facilitate spinal fusion procedures in the lumbar region. It provides structural support and alignment during the integration of bone grafts, aiding in the stabilization of vertebrae.

This device is supplied as a reusable surgical implant and is intended for use in orthopedic spinal surgeries. It is classified under FDA 510(k) clearance (K221325) and MDR authorisation, adhering to regulatory standards for orthopedic implants. No specific sterility or MRI safety details are provided in the data, but it is regulated under Class II special controls for spinal fusion devices.

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Questions

AI-generated answers, 18 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 purpose of the Conduit Lateral Switch Plate in spinal surgery?

    The Conduit Lateral Switch Plate is designed to assist in lumbar spinal fusion procedures by providing structural support and alignment during the integration of bone grafts. This helps stabilize vertebrae, ensuring proper healing and fusion in the lumbar region of the spine.

  • Is the Conduit Lateral Switch Plate intended for single-use or can it be reused?

    The device is explicitly described as a reusable surgical implant, meaning it is engineered for multiple uses in orthopedic spinal surgeries rather than being discarded after a single procedure.

  • How is the Conduit Lateral Switch Plate regulated, and what does that mean for its use?

    The device holds FDA 510(k) clearance (K221325) under the product code MAX, indicating it meets FDA standards for spinal fusion devices classified under Class II special controls. It also carries MDR authorization, ensuring compliance with European regulatory requirements for orthopedic implants.

  • Are there different sizes or models available for the Conduit Lateral Switch Plate?

    The provided data does not specify distinct sizes or model variants for the Conduit Lateral Switch Plate. For precise sizing options, you would need to consult the manufacturer’s technical documentation or contact Medos International SARL directly.