BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇫🇷 France

    Cannulated PsiFGuard

    K Number: K241895 · Decision Sep 26, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    90

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    Basic Information

    Device Name
    Cannulated PsiFGuard
    K Number
    K241895
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3040
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Spineguard
    Date Received
    June 28, 2024
    Decision Date
    September 26, 2024
    Product Code
    SCY
    Advisory Committee
    Orthopedic
    Review Advisory Committee
    OR
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    SCY Sacroiliac Joint Guidewire Placement Device