BEUDAMED
    Product Code: JDD FDA class 2 21 CFR 888.3360

    Prosthesis, Upper Femoral

    Orthopedic

    An upper femoral prosthesis is an implantable orthopedic device used to replace the proximal femur and femoral head following fracture, tumor resection, or severe degenerative disease, restoring hip joint function and load transmission from the pelvis to the femur. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket clearance before marketing. The product code is JDD, regulated under 21 CFR 888.3360, within the Orthopedic medical specialty. This device is an implant.

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    510(k)s
    0
    FEI Numbers
    3
    Registration Numbers
    3
    Unique Applicants
    0
    Years Active
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    Basic Information

    Product Code
    JDD
    Device Class
    FDA class 2
    Regulation Number
    888.3360
    Medical Specialty
    Orthopedic
    Review Panel
    OR
    Submission Type
    1

    Device Characteristics

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

    FEI Numbers

    This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.