BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    HIP, FEMUR AND HUMERUS RETRACTOR

    K Number: K880151 · Decision Feb 18, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    656
    Registration Numbers
    656
    Same Product Code
    99
    Applicant Total
    1
    Review Days
    36

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    Basic Information

    Device Name
    HIP, FEMUR AND HUMERUS RETRACTOR
    K Number
    K880151
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Twenty-First Century Orthopedics, Inc.
    Date Received
    January 13, 1988
    Decision Date
    February 18, 1988
    Product Code
    GAD
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GAD Retractor

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