BEUDAMED
    Product Code: QWK FDA class 3

    Prosthesis, Posterior Spinal Elements

    Unknown

    The posterior spinal elements prosthesis (product code QWK) is a Class 3 implantable device reviewed by the Orthopedic panel that functions as a non-fusion, load-bearing implant intended to stabilize the spine following resection of posterior spinal elements. As a Class 3 device, it requires Premarket Approval (PMA) due to the significant risks associated with spinal implantation. No regulation number has been assigned. The device is an implant but is not classified as life-sustaining.

    View on FDA
    510(k)s
    0
    FEI Numbers
    6
    Registration Numbers
    6
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    QWK
    Device Class
    FDA class 3
    Medical Specialty
    Unknown
    Review Panel
    OR
    Submission Type
    2

    Device Characteristics

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

    Definition

    This device is a non-fusion, load-bearing implanted prosthesis that stabilizes the spine following resection of posterior spinal elements.

    FEI Numbers

    This FDA classification entry is associated with 6 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 6 registration numbers. Click on an entry to view related FDA registrations.