BEUDAMED
    Product Code: LTO FDA class 3 21 CFR 888.3320

    Spacer, Cement

    Orthopedic

    The Cement Spacer (product code LTO) is an orthopedic implant used during joint replacement or revision surgery to maintain spacing, deliver antibiotics locally, or serve as a temporary joint spacer in the presence of infection. It falls under regulation 888.3320 and is classified as a Class 3 device, meaning it poses the highest risk level and requires Premarket Approval (PMA) before it can be marketed. The device is flagged as an implant, reflecting its surgical placement within the body. It is reviewed under the Orthopedic panel and is not exempt from Good Manufacturing Practice requirements.

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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
    LTO
    Device Class
    FDA class 3
    Regulation Number
    888.3320
    Medical Specialty
    Orthopedic
    Review Panel
    OR
    Submission Type
    2

    Device Characteristics

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