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510(k) Data Aggregation

    K Number
    K101609
    Device Name
    SELF RETAINING SOFT TISSUE RETRACTOR
    Manufacturer
    KOROS USA, INC.
    Date Cleared
    2010-12-09

    (184 days)

    Product Code
    LXH
    Regulation Number
    888.4540
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Device is intended for use in surgical procedures to provide surgical access to the spine by placing the retractor in incision prepared by the surgeon down towards the land the sure is michael for use in surgical procedures to provide surgical access to the specifical access to the splacing .

    Device Description

    Self-Retaining Lumbar Retractor

    AI/ML Overview

    The provided document is a 510(k) premarket notification letter from the FDA to Koros USA, Inc. regarding a Self-Retaining Lumbar Retractor. It is a regulatory approval document confirming substantial equivalence to a predicate device.

    This document does not contain any information about acceptance criteria or a study proving the device meets those criteria, as it is a Class I device and does not typically require extensive performance studies for 510(k) clearance. The information requested in the prompt (acceptance criteria table, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details, etc.) are typically found in the 510(k) submission itself or in a detailed study report, not in the FDA's clearance letter.

    Therefore, I cannot fulfill your request using the provided input.

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