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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
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K831005
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    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.

    AI/ML Overview

    The provided text is a 510(k) Pre-market Notification for the OrthoTec K-Cap System from 1997. It describes the device, its intended use, and claims substantial equivalence to predicate devices. However, it does not contain any information about acceptance criteria or a study that proves the device meets those criteria.

    510(k) submissions primarily focus on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific performance acceptance criteria through clinical studies in the same way a PMA (Pre-Market Approval) might.

    Therefore, I cannot provide the requested information from the given input. The document is a regulatory filing, not a detailed technical or clinical study report.

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