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510(k) Data Aggregation

    K Number
    K242759
    Device Name
    Geister K-Rex rongeurs
    Manufacturer
    Geister Medizin Technik GmbH
    Date Cleared
    2025-06-06

    (267 days)

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

    Geister Medizin Technik GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The GEISTER® K-Rex™ rongeurs are manually operated instruments indicated for cutting or biting bone during surgery involving the skull or spinal column.
    Device Description
    Geister Geister® K-Rex™ rongeurs are reusable stainless steel instruments that are coated with TiAIN that are sterilizable and packaged non-sterile.
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