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

    PRO-FIX PRECISION FIXATION SYSTEM MODEL PFM#, PFB#, PFT#

    K Number: K093719 · Decision Mar 1, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    71
    Registration Numbers
    71
    Same Product Code
    79
    Applicant Total
    8
    Review Days
    89

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    Basic Information

    Device Name
    PRO-FIX PRECISION FIXATION SYSTEM MODEL PFM#, PFB#, PFT#
    K Number
    K093719
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.4880
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Osteogenics Biomedical, Inc.
    Date Received
    December 2, 2009
    Decision Date
    March 1, 2010
    Product Code
    DZL
    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
    DZL Screw, Fixation, Intraosseous

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