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510(k) Data Aggregation

    K Number
    K082649
    Device Name
    SYNTHES 90 DEGREE SCREWDRIVER
    Manufacturer
    SYNTHES (USA)
    Date Cleared
    2009-04-30

    (230 days)

    Product Code
    DZI,DZJ
    Regulation Number
    872.4120
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SYNTHES 90 DEGREE SCREWDRIVER

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

    The Synthes 90 ° Screwdriver is indicated for the manual and powered pre-drilling and insertion of bone fixation screws in oral/maxillofacial surgery.

    Device Description

    The Synthes 90 ° Screwdriver consists of a screwdriver handle, shaft, screw holder, screw holder insert and a variety of attachments such as drill bits and screwdriver blades for manual and powered right angled pre-drilling and insertion of screws.

    AI/ML Overview

    This looks like a 510(k) summary for a medical device (Synthes 90° Screwdriver), and not a study report that details acceptance criteria and device performance. The given document describes the device, its intended use, classification, and substantial equivalence to a predicate device, but it does not contain the kind of detailed performance study information typically requested for AI/software-as-a-medical-device (SaMD) clearances.

    Therefore, I cannot provide the requested information about acceptance criteria and study details because the provided text does not contain this information. This document is a regulatory submission summary, not a clinical or performance study report.

    If you have a different document or a study report, I would be happy to analyze it for the requested details.

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