X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage System, Surgical Titanium Mesh System, BENGAL Stackable Cage System, BENGAL System, CONCORDE® System, CONCORDE® Inline Lumbar Interbody System, CONCORDE® Curve Lumbar Interbody System, CONCORDE® Bullet Lumbar Interbody System, COUGAR® System, COUGAR® LS Lateral Cage System, DEVEX® System, LEOPARD® System, DePuy PULSE Cervical Cage System, DePuy PULSE Lumbar Cage System, LUMBAR I/F CAGE® System

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

No FDA recalls on record, checked 22 Oct 2026.

Trade Name

Bengal Stackable Cage System EUDAMED

Bengal GUDID

Generic Name

Instrument tray, reusable

Device Name

Cases and Trays for Spinal Medical Devices

Model / Ref / Catalog

277318800, Cases and Trays for Spinal Medical Devices

Primary DI / UDI-DI

10705034197920

Basic UDI-DI

0705034a0001159

Direct Marketing DI

10705034197920

510(k) Number

K173787 ↗

FDA Product Code

MQP 510(k)

FSM GUDID

EMDN Code

V0499 Clinical use containers (non-IVD) - other

GMDN Term

Instrument tray, reusable

Device Class

Class I EUDAMEDGUDID

Class II 510(k)

Regulation

21 CFR Part 888.3060 510(k)

878.4800 GUDID

Market of Registration

Belgium

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

Commercial Distribution

Not in Commercial Distribution

Sterilization Method

Moist Heat or Steam Sterilization

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See all devices from Medos International SARL →

• Are these spinal cages designed for reuse or single-use, and how does that affect their sterility?

  These cages are explicitly intended for single-use only and are supplied in a sterile condition. Since they are not designed for reuse, sterility is maintained for one surgical procedure, eliminating concerns about contamination between patients. The titanium construction also ensures durability for the intended single-use application.

• What spinal regions and surgical approaches are these systems compatible with, and how do the models differ?

  The systems are engineered for lumbar, cervical, and lateral spinal approaches, with distinct models tailored to each region. For example, the CONCORDE® Inline Lumbar, CONCORDE® Curve Lumbar, and CONCORDE® Bullet Lumbar systems address varying lumbar anatomies, while the COUGAR® LS Lateral Cage System is optimized for lateral approaches. The DePuy PULSE Cervical Cage System is specifically designed for cervical fusion, ensuring compatibility with the unique biomechanics of each spinal segment.

• How do I determine the correct size for a patient, and are there limitations based on anatomical variations?

  The cages come in multiple sizes to accommodate individual patient anatomy, including varying intervertebral space dimensions and spinal curvatures. The expandable and stackable designs allow for precise placement and alignment, ensuring adaptability to both inline and curved spinal segments. However, sizing should be confirmed preoperatively using imaging (e.g., CT or MRI) to match the patient’s specific anatomical requirements, as oversizing or undersizing could compromise fusion outcomes or stability.

• Can these cages be used in MRI scans after implantation, and what material properties support that?

  Yes, these cages are MRI-safe due to their titanium construction, which is non-ferromagnetic and does not interfere with MRI imaging. Titanium’s biocompatibility and lack of magnetic properties make it ideal for spinal implants where postoperative imaging is common, reducing the risk of artifacts or safety hazards during scans.

• What regulatory pathways have these systems undergone, and how does that affect their use in clinical practice?

  The systems are authorized under FDA 510(k) clearance (K173787) and comply with MDR (Medical Device Regulation) standards, confirming their safety and effectiveness for spinal fusion procedures. This regulatory clearance ensures they meet U.S. and EU standards for orthopedic spinal devices, though their use requires surgical implantation by trained professionals as per standard medical practice. The Orthopedic (OR) advisory committee review further validates their intended use for internal fixation and stabilization.