BEUDAMED
    Product Code: MRA FDA class 3

    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented

    Unknown

    The Semi-Constrained Metal/Ceramic/Ceramic/Metal Hip Prosthesis (Cemented or Uncemented) is an orthopedic implant used for total hip arthroplasty, featuring bearing surfaces made of metal and ceramic components designed to reduce wear and extend prosthesis longevity. Classified as FDA Class 3 due to the novel ceramic-on-ceramic or metal-on-ceramic bearing surface configuration, it requires Premarket Approval (PMA). The product code is MRA, reviewed by the Orthopedic panel, and carries an implant flag.

    View on FDA
    510(k)s
    0
    FEI Numbers
    27
    Registration Numbers
    27
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    MRA
    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

    FEI Numbers

    This FDA classification entry is associated with 27 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 27 registration numbers. Click on an entry to view related FDA registrations.