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510(k) Data Aggregation

    K Number
    K022185
    Device Name
    UNIVERSAL CMF SYSTEM
    Manufacturer
    STRYKER INSTRUMENTS
    Date Cleared
    2002-12-17

    (167 days)

    Product Code
    JEY
    Regulation Number
    872.4760
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K014263,K002619,K862482,K854886,K953806,K993862,K862532
    Predicate For
    K031659,K032520,K072463,K080694,K091807,K161821,K170773,K171364,K172572,K220360,K221855
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Stryker® Leibinger Universal CMF System is a Cranio-maxillofacial (CMF) plate and screw system intended for osteotomy, stabilization and rigid fixation of CMF fractures and reconstruction.

    Device Description

    The Stryker Leibinger Universal CMF System is a Cranio-maxillofacial (CMF) plate and screw system.

    AI/ML Overview

    This 510(k) summary describes a Cranio-maxillofacial (CMF) plate and screw system. The document does not contain information about the acceptance criteria, device performance, or any studies proving the device meets acceptance criteria.

    The 510(k) submission states that the Universal CMF System is "substantially equivalent" to several legally marketed predicate devices. This type of submission relies on demonstrating similarity to existing devices rather than new performance studies with specific acceptance criteria.

    Therefore, the requested information regarding acceptance criteria, device performance, study details (sample size, data provenance, ground truth, expert qualifications, adjudication, MRMC studies, standalone performance, training set) is not available in the provided text.

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