BEUDAMED
    Product Code: PJY FDA class 3

    Osseoanchored Prostheses For The Rehabilitation Of Transfemoral Amputees

    Unknown

    The Osseoanchored Prostheses for Rehabilitation of Transfemoral Amputees is a percutaneous prosthetic device intended for the direct skeletal attachment of a prosthetic limb to the femur, eliminating the need for a traditional socket-based prosthesis in above-knee amputees. It is an FDA Class 3 device, requiring Pre-Market Approval (PMA) due to the high risk of a transcutaneous implant with direct skeletal fixation, reviewed by the Orthopedic (OR) panel. The product code is PJY, and it is flagged as an implant. No regulation number or medical specialty has been formally assigned.

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    510(k)s
    0
    FEI Numbers
    8
    Registration Numbers
    8
    Unique Applicants
    0
    Years Active
    —

    Basic Information

    Product Code
    PJY
    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

    The device is a percutaneous prosthetic device for the direct skeletal attachment of a prosthetic limb.

    FEI Numbers

    This FDA classification entry is associated with 8 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 8 registration numbers. Click on an entry to view related FDA registrations.