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    K Number
    K111065
    Device Name
    STRYKER (R) PATIENT SPECIFIC POLYMER IMPLANT
    Manufacturer
    HOWMEDICA OSTEONICS CORP. DBA STRYKER ORTHOPEADICS
    Date Cleared
    2011-07-14

    (87 days)

    Product Code
    GWO, KKY
    Regulation Number
    882.5320
    Why did this record match?
    Applicant Name (Manufacturer) :

    HOWMEDICA OSTEONICS CORP. DBA STRYKER ORTHOPEADICS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Stryker® Patient Specific Polymer Implant is designed individually for each patient to correct trauma and/or defects in mandibular, maxillofacial, or craniofacial bone.
    Device Description
    The Stryker Patient Specific Polymer Implant is a pre-formed plate made of cured Simplex P bone cement that is shaped to match a specific patient's bony defect based on CT scans provided by the surgeon. The plate is fixed into place using compatible Stryker plate and screw systems.
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