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510(k) Data Aggregation

    K Number
    K023088
    Device Name
    BONE GRAFT SYRINGE, MODEL 8600-00X0
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Date Cleared
    2002-10-02

    (15 days)

    Product Code
    FMF
    Regulation Number
    880.5860
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    BONE GRAFT SYRINGE, MODEL 8600-00X0

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

    The Bone Graft Syringe is intended for use as a piston syringe for aspiration of bone marrow, autologous blood, plasma, or other body fluids. The syringe can be used to mix bone graft materials with aspirated fluids and deliver the composite graft material to the orthopedic surgical site.

    Device Description

    The syringe consists of a calibrated hollow barrel and a movable plunger. At the distal end of the syringe there is a male connector nozzle for fitting the female connector (hub) of a single lumen needle. The syringe can be used for withdrawing body fluids and reinjecting the fluids and/or composite graft materials into the body.

    AI/ML Overview

    The provided text is a 510(k) summary for a Bone Graft Syringe. It describes the device, its intended use, and states that its safety and effectiveness are supported by substantial equivalence to predicate devices. However, this document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

    Specifically, the document focuses on:

    • Device Identification: Proprietary name, common name, classification, product code.
    • Intended Use: For aspiration of bone marrow, autologous blood, plasma, or other body fluids, and for mixing and delivering bone graft materials.
    • Device Description: Calibrated hollow barrel, movable plunger, male connector nozzle.
    • Substantial Equivalence Information: States that the device is substantially equivalent to previously cleared predicate devices based on intended use, materials, and design features.

    There is no mention of performance metrics, study design, sample sizes, ground truth establishment, expert qualifications, or any of the detailed information requested in your prompt regarding acceptance criteria and a study. The 510(k) process primarily relies on demonstrating substantial equivalence to pre-existing, legally marketed devices rather than requiring de novo clinical trials with specific performance acceptance criteria for this type of Class II device.

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