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510(k) Data Aggregation

    K Number
    K971453
    Device Name
    ORTHOTEC K-CAP SYSTEM
    Manufacturer
    ORTHOTECH
    Date Cleared
    1997-06-24

    (64 days)

    Product Code
    HTY
    Regulation Number
    888.3040
    Why did this record match?
    Applicant Name (Manufacturer) :

    ORTHOTECH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The OrthoTec K-Cap System is intended to provide fixation of bone fragments or for bone reconstruction, while providing protection to neighboring tissues.
    Device Description
    The OrthoTec K-Cap System includes a K-wire, a protective cap (K-Cap), and applicator/handle for attachment of the cap to the K-wire.
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