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510(k) Data Aggregation

    K Number
    K193040
    Device Name
    Resorbable Mesh Device
    Manufacturer
    SeaSpine Orthopedics Corporation
    Date Cleared
    2019-11-30

    (30 days)

    Product Code
    MQV,MBP,MOV
    Regulation Number
    888.3045
    Type
    Special
    Panel
    Orthopedic
    Reference & Predicate Devices
    K172130
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Resorbable Mesh Device is intended to fill voids and gaps in the skeletal system that are not intrinsic to the stability of the bony structure. The product is indicated for use with autograft as a bone graft extender in the posterolateral spine and pelvis. The voids or gaps may be surgically created defects or the result of traumatic injury to the bone. The Resorbable Mesh Device is resorbed/remodeled and replaced by host bone during the healing process.

    Device Description

    The Resorbable Mesh Device is comprised of a resorbable mesh pouch containing demineralized human cortical bone in particulate form. The tissue contained in the pouch is supplied to SeaSpine by a CBER-registered, AATB-accredited tissue bank and is procured, screened, tested and processed in accordance with 21 CFR 1271, Current Good Tissue Practices, AATB Standards for Tissue Banking and other standard procedures. The resorbable mesh pouch is knitted from poly(lactic-co-glycolic) acid (PLGA) fibers which have a high glycolide content.

    The Resorbable Mesh Device is offered in various sizes and provided in individually sterile packaged units and ready-to-use. The product is terminally sterilized by electron beam irradiation and validated to ensure a minimum Sterility Assurance Level (SAL) of 10-9.

    AI/ML Overview

    The provided text is related to a 510(k) premarket notification for a medical device called "Resorbable Mesh Device". It details the device's description, intended use, and a summary of non-clinical testing to support substantial equivalence to a predicate device.

    However, the document explicitly states: "Clinical Testing: Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data."

    This means the submission does not contain information about acceptance criteria, device performance, sample sizes for test sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment based on clinical data or studies proving the device meets performance criteria.

    Therefore, I cannot provide the requested information from this document.

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