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

    DALL MILES SYSTEM HOMOGENEOUS VITALLIUM CABLE

    K Number: K945294 · Decision Mar 7, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    155
    Registration Numbers
    155
    Same Product Code
    128
    Applicant Total
    373
    Review Days
    127

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    Basic Information

    Device Name
    DALL MILES SYSTEM HOMOGENEOUS VITALLIUM CABLE
    K Number
    K945294
    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
    October 31, 1994
    Decision Date
    March 7, 1995
    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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