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

    HALL STERILE BUR

    K Number: K862529 · Decision Jul 15, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    93
    Registration Numbers
    93
    Same Product Code
    3
    Applicant Total
    8
    Review Days
    13

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    Basic Information

    Device Name
    HALL STERILE BUR
    K Number
    K862529
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    888.4540
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Applicant
    Hall Surgical, Division of Zimmer, Inc.
    Date Received
    July 2, 1986
    Decision Date
    July 15, 1986
    Product Code
    HTT
    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
    HTT Burr, Orthopedic

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    K864163 HALL DUNBAR DRILL GUIDE SYSTEM
    K862778 HALL CANNLULA SYSTEM
    K862474 HALL STERNUM SAW
    K852143 HALL IRRIGATION SYSTEM