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510(k) Data Aggregation

    K Number
    K181282
    Device Name
    G3A 40 Bone Cement
    Manufacturer
    G21 S.r.l
    Date Cleared
    2019-01-09

    (239 days)

    Product Code
    LOD,MBB
    Regulation Number
    888.3027
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    G3A 40 Bone Cement

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Not Found

    Device Description

    Not Found

    AI/ML Overview

    The provided text is an FDA 510(k) clearance letter for a bone cement device (G3A 40 Bone Cement). It confirms that the device is substantially equivalent to legally marketed predicate devices.

    However, this document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details. These types of details are typically found in the 510(k) summary or the full submission, not in the clearance letter itself.

    Therefore, I cannot provide the requested information based on the text provided.

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