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510(k) Data Aggregation

    K Number
    K990212
    Date Cleared
    1999-09-14

    (235 days)

    Product Code
    Regulation Number
    872.4600
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    LOCKJAW 15 MINUTE INTERMAXILLARY FIXATION SYSTEM,MODEL LJ100-00

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

    The DRG LockJaw™ 15 Minute Intermaxillary Fixation System is intended for secondary intermaxillary fixation in the treatment of maxillary and mandibular fractures, in elective orthognathic surgery and in the stabilization of dental and dentoalveolar injuries.

    Device Description

    DRG LockJaw™ 15 Minute Intermaxillary Fixation System

    AI/ML Overview

    This is a scanned FDA letter for a 510k submission for the DRG LockJaw™ 15 Minute Intermaxillary Fixation System. Unfortunately, the letter does not contain the requested information (acceptance criteria, study details, sample sizes, expert qualifications, etc.).

    The letter simply states that the FDA has reviewed the 510(k) notification and determined the device is substantially equivalent to legally marketed predicate devices. It grants permission to market the device subject to general controls. The letter also includes the stated indications for use of the device.

    Therefore, I cannot provide the detailed information you requested based solely on the provided text. To get this information, you would typically need to review the full 510(k) summary or submission documents, which are not included here.

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