BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇹🇼 Taiwan

    Caduceus S

    K Number: K220554 · Decision Dec 16, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35
    Same Product Code
    41
    Applicant Total
    2
    Review Days
    291

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    Basic Information

    Device Name
    Caduceus S
    K Number
    K220554
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4560
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Taiwan Main Orthopaedic Biotechnology Co., Ltd.
    Date Received
    February 28, 2022
    Decision Date
    December 16, 2022
    Product Code
    SBF
    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
    SBF Orthopedic Augmented Reality

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    Other Clearances by Taiwan Main Orthopaedic Biotechnology Co., Ltd.

    K Number Device Name
    K242271 Caduceus S