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

    FRACTURE REDUCTION SYS., MODEL OR 1001

    K Number: K770388 · Decision Mar 14, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    66
    Registration Numbers
    66
    Same Product Code
    84
    Applicant Total
    1
    Review Days
    14

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    Basic Information

    Device Name
    FRACTURE REDUCTION SYS., MODEL OR 1001
    K Number
    K770388
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3040
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Applicant
    Sisan Assoc.
    Date Received
    February 28, 1977
    Decision Date
    March 14, 1977
    Product Code
    JEC
    Advisory Committee
    Orthopedic
    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
    JEC Component, Traction, Invasive

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