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

    STRYKER LEIBINGER SKELETAL ANCHORING SYSTEM

    K Number: K041651 · Decision Sep 30, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    324
    Registration Numbers
    324
    Same Product Code
    1545
    Applicant Total
    12
    Review Days
    105

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    Basic Information

    Device Name
    STRYKER LEIBINGER SKELETAL ANCHORING SYSTEM
    K Number
    K041651
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3640
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Stryker Leibinger
    Date Received
    June 17, 2004
    Decision Date
    September 30, 2004
    Product Code
    DZE
    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
    DZE Implant, Endosseous, Root-Form

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