BEUDAMED
    Product Code: OQB FDA class 2 21 CFR 888.3085

    Intervertebral Body Graft Containment Device

    Orthopedic

    The Intervertebral Body Graft Containment Device (product code OQB) is a non-rigid implanted spinal device designed to contain bone graft material within an internal cavity. It is inserted into the intervertebral body space of the spine and functions as an adjunct to intervertebral body fusion procedures. As an FDA Class 2 orthopedic device under regulation 888.3085, it requires 510(k) premarket clearance to demonstrate substantial equivalence to a predicate device. This device is flagged as an implant, meaning it is placed inside the body, though it is not life-sustaining. It falls within the Orthopedic medical specialty.

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    510(k)s
    4
    FEI Numbers
    2
    Registration Numbers
    2
    Unique Applicants
    1
    Years Active
    5

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    Basic Information

    Product Code
    OQB
    Device Class
    FDA class 2
    Regulation Number
    888.3085
    Medical Specialty
    Orthopedic
    Review Panel
    OR
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✓
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    An intervertebral body graft containment device is a non-rigid, implanted spinal device that is designed to contain bone graft within its internal cavity. The device is inserted into the intervertebral body space of the spine and is intended as an adjunct to intervertebral body fusion.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 4 510(k) clearances via K numbers.

    K Number Device Name
    K251302 OptiMesh Multiplanar Expandable Interbody Fusion System
    K230927 OptiMesh Multiplanar Expandable Interbody Fusion System
    K231781 OptiMesh Multiplanar Expandable Interbody Fusion System
    DEN200010 Spineology Interbody Fusion System

    FEI Numbers

    This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.