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

    DALL MILES SYSTEM MINICLEAT

    K Number: K934058 · Decision Feb 23, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    155
    Registration Numbers
    155
    Same Product Code
    128
    Applicant Total
    373
    Review Days
    188

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    Basic Information

    Device Name
    DALL MILES SYSTEM MINICLEAT
    K Number
    K934058
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3010
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    Howmedica Corp.
    Date Received
    August 19, 1993
    Decision Date
    February 23, 1994
    Product Code
    JDQ
    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
    JDQ Cerclage, Fixation

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    Other Clearances by Howmedica Corp.

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    K980632 DURATION II TIBIAL INSERTS - GAS PLASMA STERILIZATION
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    K983419 HOFFMANN II MIAMI POST
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