BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇸🇪 Sweden

    OTS Hip

    K Number: K250086 · Decision May 16, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    370
    Registration Numbers
    370
    Same Product Code
    404
    Applicant Total
    3
    Review Days
    123

    Basic Information

    Device Name
    OTS Hip
    K Number
    K250086
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4560
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ortoma AB
    Date Received
    January 13, 2025
    Decision Date
    May 16, 2025
    Product Code
    OLO
    Advisory Committee
    Neurology
    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
    OLO Orthopedic Stereotaxic Instrument

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    Other Clearances by Ortoma AB

    K Number Device Name
    K232140 OTS Hip
    K181449 Ortoma Treatment Solution - OTS