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510(k) Data Aggregation

    K Number
    K162864
    Device Name
    OsteoVation Impact
    Manufacturer
    Skeletal Kinetics, LLC.
    Date Cleared
    2017-01-13

    (92 days)

    Product Code
    GXP
    Regulation Number
    882.5300
    Why did this record match?
    Applicant Name (Manufacturer) :

    Skeletal Kinetics, LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Osteo Vation Impact is a calcium phosphate bone void filler indicated for the repair or filling of neurosurgical burr holes, other cranialbone defects and craniotomy cuts with a surface area no larger than 25cm2. OsteoVation Impact may be used in the restoration or augmentation of bony contours of the cranialbone skeleton.
    Device Description
    OsteoVation Impact is a self-setting, calcium phosphate bone void filler designed for single use and biocompatible. Osteo Vation Impact is an impactable (moldable) calcium phosphate. OsteoVation Impact is comprised of two working components: a calcium phosphate, a sodium phosphate (SPMA), carboxymethylcellulose powder, a sodium silicate, sodium phosphate (SPMA) solution, and a mixing system (mixing bowl, pestle and spatula). The two working components are packaged separately and are to be mixed together by the end user prior to implantation. OsteoVation Impact is offered in 3cc, 5cc, and 10cc sterile convenience kits. Each kit includes the two working components in combination with a mixing bowl, pestle, and spatula. It is sterilized using gamma radiation with a minimum dose of 25 kGy and a maximum dose of 50 kGy with a Sterility Assurance Level of 10-9.
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