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510(k) Data Aggregation

    K Number
    K180949
    Device Name
    Steribite
    Manufacturer
    RJR Surgical, Inc.
    Date Cleared
    2018-11-08

    (211 days)

    Product Code
    HAE
    Regulation Number
    882.4840
    Why did this record match?
    Applicant Name (Manufacturer) :

    RJR Surgical, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Steribite® Rongeur is a manually operated instrument indicated for cutting bone during surgery involving the skull or spinal column.
    Device Description
    Steribite® is a system of disposable manual surgical Kerrison rongeurs. The instruments are offered in a 40° up configuration having shaft lengths of 8 and 11 inches and bite sizes 1mm to 5mm to accommodate variations in surgical need. The devices are sold sterile and single use only.
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