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510(k) Data Aggregation

    K Number
    K070761
    Device Name
    SANATMETAL NAILS AND PINS
    Manufacturer
    SANATMETAL MFR. OF ORTHOPAEDIC/TRAUMATOLOGIC PROD.
    Date Cleared
    2008-02-07

    (324 days)

    Product Code
    HSB
    Regulation Number
    888.3020
    Why did this record match?
    Applicant Name (Manufacturer) :

    SANATMETAL MFR. OF ORTHOPAEDIC/TRAUMATOLOGIC PROD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Indications for the Sanatmetal Intramedullary Nails and Pins include traumatologic implants for the intramedullary fixation of fractures of tubular bones (femur, tibia, humerus), nonunions and malunions, i.e. diaphysis fractures, sub-trochanter fractures and femoral sub-trochanter fractures combined with diaphysis fractures, extra- and intraarticular fractures. Sanatmetal Intramedullary Nails and Pins are single use devices.
    Device Description
    The device is a stainless steel or titanium alloy nail for orthopaedic implantation. Depending on the model selected, the device may have none, any or all of the following features: cannulation, endcaps, slots, holes, anodized finish (titanium models only), locking screws.
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