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

    ORTHOPEDIC SOFT GOODS

    K Number: K771109 · Decision Jun 27, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49
    Same Product Code
    2
    Applicant Total
    95
    Review Days
    7

    Basic Information

    Device Name
    ORTHOPEDIC SOFT GOODS
    K Number
    K771109
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    888.5890
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Applicant
    ORTHOPEDIC SYSTEMS, INC.
    Date Received
    June 20, 1977
    Decision Date
    June 27, 1977
    Product Code
    HSS
    Advisory Committee
    Orthopedic
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HSS Halter, Head, Traction

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