BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    OsteoProbe (OP-100)

    K Number: K250216 · Decision Sep 11, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    2
    Applicant Total
    3
    Review Days
    230

    Basic Information

    Device Name
    OsteoProbe (OP-100)
    K Number
    K250216
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.1600
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Active Life Scientific, Inc.
    Date Received
    January 24, 2025
    Decision Date
    September 11, 2025
    Product Code
    QGQ
    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
    QGQ Bone Indentation Device

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    Other Clearances by Active Life Scientific, Inc.

    K Number Device Name
    K221195 OsteoProbe
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