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510(k) Data Aggregation

    K Number
    K073556
    Device Name
    MEDXPERT P.E.S. (PECTUS EXACVATUM SYSTEM), MEDXPERT STRATOS
    Manufacturer
    MEDXPERT GMBH
    Date Cleared
    2008-06-24

    (188 days)

    Product Code
    HRS
    Regulation Number
    888.3030
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDXPERT GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MedXpert's P.E.S. implant system is intended for use in surgical procedures to repair Pectus Excavatum and other sternal deformities. MedXpert's STRATOS™ implant system is intended to stabilize and provide fixation for fractures, fusions, and osteotomies of the ribs, and reconstructions of chest wall and sternum.
    Device Description
    MedXpert's P.E.S. implant system is consisting out of straight bars which can be bended according to the individual anatomic needs of the patient and different stabilizer which can be attached to the bar and secured by the BarLock™ Pin. MedXpert's STRATOS™ implant system is consisting out of Bar and Rip Clips; Rip Clips are combined by press fit with the bar and with the rips.
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