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

    THE TITANIUM FIXATION SYSTEM

    K Number: K943071 · Decision Jan 6, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    106
    Registration Numbers
    106
    Same Product Code
    291
    Applicant Total
    10
    Review Days
    192

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    Basic Information

    Device Name
    THE TITANIUM FIXATION SYSTEM
    K Number
    K943071
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.4760
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biomedics
    Date Received
    June 28, 1994
    Decision Date
    January 6, 1995
    Product Code
    JEY
    Advisory Committee
    Dental
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JEY Plate, Bone

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