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    K Number
    K071628
    Device Name
    STRYKER EXTERNAL FIXATION SYSTEM
    Manufacturer
    STRYKER CMF
    Date Cleared
    2007-08-10

    (57 days)

    Product Code
    MQN, KTT
    Regulation Number
    872.4760
    Why did this record match?
    Applicant Name (Manufacturer) :

    STRYKER CMF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Stryker® External Fixation System is intended to stabilize and provide treatment for fractures of the maxillofacial area, including severe open mandibular fractures, highly comminuted closed fractures, nonunions and delayed unions (especially associated with infection), fractures associated with infections, turnor resections, facial deformity corrections, gunshot wounds, pan facial fractures, burn maintenance, and bone grafting defects.
    Device Description
    Not Found
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    K Number
    K060750
    Device Name
    STRYKER INJECTABLE CEMENT
    Manufacturer
    STRYKER CMF
    Date Cleared
    2006-04-19

    (29 days)

    Product Code
    NEA
    Regulation Number
    872.3275
    Why did this record match?
    Applicant Name (Manufacturer) :

    STRYKER CMF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Stryker® Injectable Cement is indicated for use in the following: augmentation or coupling of the middle ear ossicles, attachment of the middle ear ossicles to middle ear implants, mechanical stabilization of middle ear prostheses, and the reconstruction of the posterior canal wall.
    Device Description
    Hydroxyapatite Cement. Powder and liquid mixed to form a paste for application. Injectable Cement. Calcium Phosphate material. Sterile.
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