LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K031989
    Device Name
    ORTRAUTEK ORTHOGNATHIC SYSTEM
    Manufacturer
    TEKKA
    Date Cleared
    2003-10-28

    (123 days)

    Product Code
    JEY
    Regulation Number
    872.4760
    Type
    Traditional
    Panel
    Dental Devices (DE)
    Reference & Predicate Devices
    K854886,K974555,K021618,K944561,K944565,K953385,K012910
    Why did this record match?
    Device Name :

    ORTRAUTEK ORTHOGNATHIC SYSTEM

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

    The ORTRAUTEK ORTHOGNATHIC SYSTEM is intended for oral, maxillofacial surgery: selective trauma, reconstructive surgery, and selective orthognathic surgeries on maxilla and mandible.

    Device Description

    The ORTRAUTEK ORTHOGNATHIC SYSTEM is composed of bone plates and bone screws of various shapes and sizes, and associated accessories for use in oral and maxillofacial surgery. The accessories include the instruments used to implant bone plates and screws. These accessories include screwdrivers, forceps, and drills. The bone plates meet ASTM F67 standards of unalloyed titanium surgical implants. The bone screws meet ASTM F136 standards. The system contains various shapes and sizes of plates. The thickness of these plates is either 1.0 mm, 0.6 mm, or 0.8 mm. The system contains bone screws that are 2.0 mm, 2.4 mm, or 1.5MM.

    AI/ML Overview

    I am sorry, but based on the limited information provided in the given text, I cannot describe the acceptance criteria and the study that proves the device meets them. The text primarily focuses on the 510(k) summary for the "ORTRAUTEK ORTHOGNATHIC SYSTEM," detailing its description, predicate devices, and intended use as part of its substantial equivalence claim to previously marketed devices.

    There is no mention of:

    • Acceptance criteria: Specific performance metrics or thresholds the device needs to meet.
    • A study proving acceptance criteria: Details about any clinical or performance studies, their design, results, or statistical analyses.
    • Sample sizes: For test sets or training sets.
    • Data provenance, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

    The document is a premarket notification (510(k)) that argues for substantial equivalence primarily based on material, design, composition, function, and intended use being identical or similar to predicate devices. It does not contain the kind of detailed performance study information typically found when a device is evaluated against specific acceptance criteria.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1