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CONDUIT Lateral Lumbar Intervertebral Fusion Cage, CONDUIT Instruments

by Medos International SARL

510(k) K223688

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 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K223688↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK223688 Date8 Mar 2023ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 25 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  • Withdrawn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
FDA applicant
Medos International Sàrl
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 Lumbar Intervertebral Fusion Cage is a spinal implant designed for lateral lumbar interbody fusion. It is classified as an intervertebral cage intended to facilitate bone fusion between adjacent vertebrae in the lumbar spine, providing structural support and promoting bony integration.

This device is supplied as a sterile, single-use implant system, including both the fusion cage and associated instrumentation. It is intended for use in surgical settings where lateral lumbar interbody fusion procedures are performed, adhering to standard orthopedic surgical protocols. The device holds FDA 510(k) clearance under the Traditional 510(k) Review pathway and is compliant with the EU Medical Device Regulation (MDR).

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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 types of spinal procedures is the CONDUIT™ Lateral Lumbar Intervertebral Fusion Cage specifically designed for?

    The CONDUIT™ Lateral Lumbar Intervertebral Fusion Cage is designed exclusively for lateral lumbar interbody fusion procedures. This technique involves placing the cage between adjacent lumbar vertebrae from a lateral (side) approach to stabilize the spine, promote bone fusion, and restore structural integrity in the lumbar region.

  • Is the CONDUIT™ system intended for reuse in multiple surgeries, or is it meant to be used only once?

    The CONDUIT™ Lateral Lumbar Intervertebral Fusion Cage and its associated instrumentation are supplied as a sterile, single-use system. This means each package is intended for one surgical procedure only, adhering to best practices for infection control and patient safety.

  • What regulatory pathways has the CONDUIT™ system undergone, and how does this affect its use?

    The CONDUIT™ system holds FDA clearance under the Traditional 510(k) Review pathway, specifically classified as substantially equivalent (SESE) to a predicate device. It is also compliant with the EU Medical Device Regulation (MDR), ensuring it meets both U.S. and European standards for spinal fusion implants. This clearance confirms its adherence to safety and performance requirements for lateral lumbar interbody fusion procedures.

  • How is the CONDUIT™ system packaged and prepared for use in the operating room?

    The CONDUIT™ system is supplied as a sterile, pre-packaged implant system, including both the fusion cage and the necessary instrumentation. This ensures readiness for immediate use in surgical settings, minimizing preparation time and maintaining sterility throughout the procedure.