LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K021618
    Device Name
    OSA RIGID INTERNAL FIXATION SYSTEM
    Manufacturer
    OSTEOMED CORP.
    Date Cleared
    2002-08-08

    (84 days)

    Product Code
    JEY
    Regulation Number
    872.4760
    Type
    Traditional
    Panel
    Dental Devices (DE)
    Reference & Predicate Devices
    K980199,K944565
    Why did this record match?
    Device Name :

    OSA RIGID INTERNAL FIXATION SYSTEM

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

    OsteoMed OSA Rigid Internal Fixation System is intended for a variety of pan facial indications. Specifically, the system is intended for selective trauma of the midface and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and mandible. Implants are single use only.

    Device Description

    The OsteoMed OSA Rigid Internal Fixation System is comprised of various plates and screws. Plates, .8mm through 1.0mm thick, are provided in various shapes and sizes. Screws are provided in 1.6mm and 2.0mm diameter in lengths of 4.0mm through 8.0mm. Safety screws are 1.9mm and 2.4mm diameter. Depth gauges, screwdrivers, countersinks, pilot drills, and preparation instruments will also be a part of the system.

    AI/ML Overview

    This 510(k) summary describes a physical medical device (OsteoMed OSA Rigid Internal Fixation System) and not an AI/ML powered software device. Therefore, the requested information about acceptance criteria, study details, ground truth, and training set is not applicable to this document. The submission focuses on demonstrating substantial equivalence to predicate devices based on similarities in intended use, material, design, and operational principles.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1