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

    SPRYTIE, MODELS ST001, ST002 AND ST003

    K Number: K092530 · Decision Apr 2, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    1
    Applicant Total
    1
    Review Days
    227

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    Basic Information

    Device Name
    SPRYTIE, MODELS ST001, ST002 AND ST003
    K Number
    K092530
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.4880
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Russell B. Walther
    Date Received
    August 18, 2009
    Decision Date
    April 2, 2010
    Product Code
    DZK
    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
    DZK Wire, Fixation, Intraosseous

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