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    K Number
    K981275
    Device Name
    SYNTHES (USA) RATCHETING DISTRACTOR
    Manufacturer
    SYNTHES (USA)
    Date Cleared
    1998-06-25

    (78 days)

    Product Code
    MQN
    Regulation Number
    872.4760
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Synthes Ratcheting Distractor is intended for craniofacial surgery, reconstructive procedures, and selective orthognathic surgery of the mandible and maxilla. Specifically, it is indicated for correcting deficiencies in craniofacial bones, especially orthognathic mandible lengthenings.

    Device Description

    The Synthes Ratcheting Distractor is an intra-oral distraction device. It features two telescoping components, with contoured legs that have threaded screw holes, that are fixed to bone via 1.3 mm - 3.0 mm screws. The distractor is available in right and left versions; has a ratcheting mechanism that is activated by an "activation instrument"; and is capable of distraction lengths of up to 30 mm. It is manufactured from a titanium alloy.

    AI/ML Overview

    The provided document is a 510(k) summary for the Synthes Ratcheting Distractor, a medical device. This type of document is for regulatory clearance of a new device based on its substantial equivalence to a legally marketed predicate device.

    It describes the device itself, its intended use, and identifies a predicate device. However, it does not contain the information requested in your prompt regarding acceptance criteria, performance studies, sample sizes, expert involvement, or any form of AI/algorithm performance.

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

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