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510(k) Data Aggregation

    K Number
    K193075
    Device Name
    Osteo3 ZP Putty
    Manufacturer
    Sirakoss Ltd.
    Date Cleared
    2020-06-09

    (218 days)

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

    Sirakoss Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Osteo3 ZP Putty is indicated for filling bone voids or defects of the skeletal system (i.e., the extremities, pelvis, and posterolateral spine) that are not intrinsic to the stability of the bony structure. These osseous defects may be surgically created or as a result of traumatic injury to the bone. Osteo3 ZP Putty is a bone graft putty that is resorbed and replaced with bone during the healing process. Osteo3 ZP Putty must be used with morselized autograft bone at a ratio of 1:1 by volume in the posterolateral spine.
    Device Description
    Osteo3 ZP Putty is an osteoconductive, resorbable, porous, 100% nanosynthetic calcium phosphate bone void filler. Osteo ZP Putty contains 5.8 wt% silicon-substituted calcium phosphate granules suspended in a resorbable polymer gel. The final, finished Osteo2 ZP Putty is 30 wt% granules and 70 wt% polymer gel. The high surface area porous granules have been designed to deliver consistent and rapid bone ingrowth, remodeling and cell-mediated resorption during the bone healing process. The aqueous polymer gel phase binds the highly porous granules into a moldable, pliable formulation which enables Osteo3 ZP Putty to be implanted directly from the packaging without any further gelation, mixing or graft setting time. Osteo3 ZP Putty is provided sterile to the end user in 5 cc and 10 cc sizes.
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