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Bengal Stackable Cage System

by Medos International SARL

510(k) K190284

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) K190284↗

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 NumberK190284 Date20 Dec 2019ClearedStatusActive
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  • Withdrawn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
PLR
Device Class
Class II
Regulation
21 CFR Part 888.3060
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 Bengal Stackable Cage System is a Spinal Vertebral Body Replacement Device for cervical use, classified as a Class II medical device. It is designed to provide structural support and stability to the cervical spine by replacing a vertebral body, facilitating spinal reconstruction and fusion.

This system is supplied as a reusable surgical implant constructed from a polymer/carbon-fiber composite, featuring ridges or teeth to enhance fixation. It is intended for use in orthopedic surgical settings and has received FDA 510(k) clearance under K190284, as well as MDR authorization. Multiple sizes and configurations are available, as indicated by the listed FEI numbers, ensuring compatibility with various anatomical requirements.

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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 Bengal Stackable Cage System in spinal surgery?

    The Bengal Stackable Cage System is designed to replace a cervical vertebral body, providing structural support and stability to the cervical spine. It is intended for spinal reconstruction and fusion procedures, helping to maintain proper alignment and promote healing in orthopedic surgical settings.

  • Is the Bengal Stackable Cage System intended for single-use or can it be reused?

    The Bengal Stackable Cage System is explicitly described as a reusable surgical implant, constructed from a polymer/carbon-fiber composite. This material composition and design classification align with reusable medical devices, though proper sterilization and handling protocols must be followed per manufacturer guidelines.

  • How many different sizes or configurations are available for the Bengal Stackable Cage System?

    The system comes in multiple sizes and configurations, as evidenced by the extensive list of FEI numbers (e.g., 3005819474, 3003935342, etc.) provided in the regulatory data. These variations ensure compatibility with diverse anatomical requirements in cervical spine procedures.

  • What regulatory pathways has the Bengal Stackable Cage System undergone, and where is it manufactured?

    The device has received FDA 510(k) clearance (K190284) under the Traditional pathway and MDR authorization, confirming its compliance with U.S. and EU regulatory standards. It is manufactured by Medos International Sarl, based at Chemin-Blanc 38, Lelocle, Switzerland (postal code 2400).

  • Are there any specific features of the Bengal Stackable Cage System that enhance its fixation in spinal procedures?

    Yes, the system includes ridges or teeth on its design, which are intended to improve fixation and stability when placed within the cervical vertebral body. This feature helps secure the implant in place during spinal reconstruction and fusion.