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510(k) Data Aggregation

    K Number
    K990537
    Device Name
    OSTEO-PIN MEMBRANE FIXATION PIN
    Manufacturer
    LUITPOLD PHARMACEUTICALS, INC.
    Date Cleared
    1999-11-19

    (273 days)

    Product Code
    LYC
    Regulation Number
    872.3930
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    OSTEO-PIN MEMBRANE FIXATION PIN

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

    OSTEO-PIN is used to attach absorbable and non-absorbable membranes used for guided tissue regeneration and guided bone regeneration to underlying bone.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for a medical device (OSTEO-PIN Membrane Fixation Pin). It states that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory obligations.

    The document does not contain any information about acceptance criteria for a study, reported device performance, sample sizes, expert qualifications, adjudication methods, details of comparative effectiveness studies (MRMC), standalone algorithm performance, or ground truth establishment.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the input provided.

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