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510(k) Data Aggregation

    K Number
    K141429
    Device Name
    SORRENTO BONE GRAFT SUBSTITUTE
    Manufacturer
    HAIDER BIOLOGICS, LLC
    Date Cleared
    2015-02-23

    (269 days)

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

    HAIDER BIOLOGICS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Sorrento Bone Graft Substitute is intended for use as a bone void filler to fill voids or gaps of the skeletal system in the extremities and pelvis not intrinsic to the stability of the bony structure. Sorrento Bone Graft Substitute is also indicated for use in the treatment of surgically treated osseous defects or osseous defects created from traumatic injury to the bone. Sorrento Bone Graft Substitute must be wetted with bone marrow aspirate. Following placement in the bony you'd or gap (defect), Sorrento Bone Graft Substitute is resorbed and replaced with bone during the healing process.
    Device Description
    Sorrento Bone Graft Substitute is a resorbable bone void filler made from a matrix of highly purified collagen (ASTM F2212) that has high porosity beta tricalcium phosphate (TCP) granules (ASTM F1088) dispersed throughout. The implant is provided as sterile, non-pyrogenic, and for single use in double peel packages.
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