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510(k) Data Aggregation

    K Number
    K242782
    Device Name
    GlassBone Granules
    Manufacturer
    Noraker
    Date Cleared
    2024-12-23

    (98 days)

    Product Code
    MQV
    Regulation Number
    888.3045
    Why did this record match?
    Applicant Name (Manufacturer) :

    Noraker

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    GlassBone Granules is an implant intended to fill bony voids or gaps of the skeletal system (i.e., extremities and pelvis). These osseous defects may be the result of benign bone cysts and tumors (in adults and pediatric patients ≥ 6 years old), are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. GlassBone Granules resorbs and is replaced with bone during the healing process.
    Device Description
    GlassBone Granules is a synthetic and biocompatible bone substitute device (bioactive glass 4555). GlassBone Granules is composed by weight of 4555 bioactive glass granules (45% SiO2, 6% P2O5, 24.5% CaO and 24.5% Na2O). It is sterilized with gamma irradiation and is single use and is available in different unit sizes.
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