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510(k) Data Aggregation

    K Number
    K010246
    Manufacturer
    Date Cleared
    2001-02-14

    (19 days)

    Product Code
    Regulation Number
    888.1100
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    KYPHX INFLATABLE BONE TAMP, SIZE 20/3,MODEL K01A, KYPHX INFLATABLE BONE TAMP, SIZE 15/3, MODEL K02A

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
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