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510(k) Data Aggregation

    K Number
    K030605
    Device Name
    RAPID IMF
    Manufacturer
    ZYGOMATICS LTD.
    Date Cleared
    2003-06-27

    (122 days)

    Product Code
    DYX
    Regulation Number
    872.4600
    Why did this record match?
    Applicant Name (Manufacturer) :

    ZYGOMATICS LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Rapid IMF is an adjustable flexible plastic band that wraps around a tooth to create an anchorage point for maxillo-mandibular fixation and immobilisation (similar to an orthodontic band). Rapid IMF is suitable for: - Pre-operative fixation - Per-operative fixation - Short-term (up to 3 weeks) fixation for minimally displaced fractures - Splintage post jaw dislocation
    Device Description
    The Rapid IMF is an adjustable flexible plastic band that wraps around a tooth to create an anchorage point for maxillo-mandibular fixation and immobilisation (similar to an orthodontic band).
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