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510(k) Data Aggregation

    K Number
    K223563
    Device Name
    OsteoCNX
    Manufacturer
    Converg Engineering
    Date Cleared
    2023-01-25

    (57 days)

    Product Code
    MQV
    Regulation Number
    888.3045
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    OsteoCNX Bone Graft Substitute is intended for use as a bone void filler to fill voids or gaps of the skeletal system not intrinsic to the stability of the bony structure (extremities, pelvis, posterior lateral spine). OsteoCNX Bone Graft Substitute is also indicated for use in the treatment of surgically created osseous defects created from traumatic injury to the bone. OsteoCNX Bone Graft Substitute must be wetted with bone marrow aspirate or, when used in the posterolateral spine, autologous bone must also be added (50/50 ratio by volume). Following placement in the bony void or gap (defect), OsteoCNX Bone Graft Substitutes are resorbed with bone during the healing process

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain any information about acceptance criteria or a study that proves a device meets such criteria. The document is an FDA clearance letter for a device called "OsteoCNX" and primarily discusses regulatory information and the device's indications for use. No performance metrics, study details, or ground truth information are present.

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