BEUDAMED
    Product Code: HRZ FDA class 3 21 CFR 888.3480

    Prosthesis, Knee, Hinged (Metal-Metal)

    Orthopedic

    A hinged (metal-metal) knee prosthesis is a fully constrained knee replacement implant with a rigid hinge mechanism connecting the femoral and tibial components, used in patients requiring maximum joint stability where other prosthesis types are unsuitable. It is classified as an FDA Class 3 device under 21 CFR 888.3480, the highest risk category, and requires a Premarket Approval (PMA) application demonstrating safety and effectiveness. Product code HRZ falls under the Orthopedic medical specialty. PMAs for this device type were required to be filed by 12/26/96 per 61 FR 50710 (9/27/96). This device is an implant.

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    510(k)s
    0
    FEI Numbers
    1
    Registration Numbers
    1
    Unique Applicants
    0
    Years Active
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    Basic Information

    Product Code
    HRZ
    Device Class
    FDA class 3
    Regulation Number
    888.3480
    Medical Specialty
    Orthopedic
    Review Panel
    OR
    Submission Type
    2

    Device Characteristics

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

    Definition

    PMAs to be filed by 12/26/96 (61 FR 50710 (9/27/96))

    FEI Numbers

    This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.