BEUDAMED
    Product Code: KWK FDA class 2 21 CFR 888.3030

    Appliance, Nail/Blade/Plate Combination, Single Component

    Orthopedic

    The Single Component Nail/Blade/Plate Combination Appliance is a one-piece orthopedic internal fixation device used to stabilize fractures of the proximal femur, combining a nail or blade element with a lateral plate in a unitary construct. It is classified as FDA Class 2, indicating moderate risk, and requires a 510(k) premarket notification prior to marketing. The product code is KWK, regulated under 21 CFR 888.3030, in the Orthopedic medical specialty. This device is an implant.

    View on FDA
    510(k)s
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    KWK
    Device Class
    FDA class 2
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Review Panel
    OR
    Submission Type
    1

    Device Characteristics

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

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 1 510(k) clearance via K numbers.

    K Number Device Name
    K931682 CANNULATED MALLEOLAR SCREW