BEUDAMED
    Product Code: LML FDA class 3

    Ligaments And Tendons, Synthetic

    Unknown

    Ligaments and Tendons, Synthetic are prosthetic devices made from synthetic materials designed to replace or augment damaged or torn ligaments and tendons, used in orthopedic reconstructive surgery of joints such as the knee, shoulder, or ankle to restore mechanical stability and function. This is an FDA Class 3 device, the highest risk category, requiring Premarket Approval (PMA) to demonstrate safety and effectiveness. The product code is LML; no regulation number has been assigned, and the review panel is Orthopedic. This device is an implant.

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

    Product Code
    LML
    Device Class
    FDA class 3
    Medical Specialty
    Unknown
    Review Panel
    OR
    Submission Type
    2

    Device Characteristics

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