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

    COLLAGEN TENDON SHEET-DDI (CTS-DDI)

    K Number: K140300 · Decision Mar 26, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    32
    Registration Numbers
    32
    Same Product Code
    13
    Applicant Total
    5
    Review Days
    48

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    Basic Information

    Device Name
    COLLAGEN TENDON SHEET-DDI (CTS-DDI)
    K Number
    K140300
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.3300
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Rotation Medical, Inc.
    Date Received
    February 6, 2014
    Decision Date
    March 26, 2014
    Product Code
    OWY
    Advisory Committee
    General, Plastic Surgery
    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
    OWY Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon

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