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

    BIOMECHANIC LOW-PROFILE CABLE SYSTEM

    K Number: K951844 · Decision Jul 13, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    155
    Registration Numbers
    155
    Same Product Code
    128
    Applicant Total
    1
    Review Days
    84

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    Basic Information

    Device Name
    BIOMECHANIC LOW-PROFILE CABLE SYSTEM
    K Number
    K951844
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3010
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    Biomechanic, Inc.
    Date Received
    April 20, 1995
    Decision Date
    July 13, 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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