BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Prosthesis, Spinous Process Tension Band Implant

    PMA: P220031 · Decision Feb 12, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Prosthesis, Spinous Process Tension Band Implant
    Trade Name
    LimiFlex Dynamic Sagittal Tether
    PMA Number
    P220031
    Device Class
    FDA Class 3
    Product Code
    SGK
    Generic Name
    Prosthesis, spinous process tension band implant
    Medical Specialty
    Unknown
    Advisory Committee
    Orthopedic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    February 12, 2026
    Date Received
    December 19, 2022
    Expedited Review
    N
    Docket Number
    FDA-1892

    Advisory Committee Statement

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    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    SGK Prosthesis, Spinous Process Tension Band Implant