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510(k) Data Aggregation

    K Number
    K982927
    Device Name
    QUICK TAP SELF DRILLING SCREW
    Manufacturer
    KINAMED, INC.
    Date Cleared
    1998-09-08

    (19 days)

    Product Code
    DZL
    Regulation Number
    872.4880
    Type
    Special
    Panel
    Dental
    Reference & Predicate Devices
    K964362
    Why did this record match?
    Device Name :

    QUICK TAP SELF DRILLING SCREW

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

    The Kinamed NeuroPro™ , Quick Tap™ Self Drilling Screws are indicated for use in conjunction with bone plates and mesh implants of the parent NeuroPro System in internal fixation of fractures and osteotomies of the craniofacial skeleton including fixation of cranial bone flap osteotomies as well as for reconstruction of bony defects and deficits of the craniofacial skeleton.

    The Kinamed NeuroPro™ , Quick Tap™ Self Drilling Screws are not indicated for use in the spine.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter from the FDA, along with the indications for use for the Kinamed NeuroPro™, Quick Tap™ Self Drilling Screws. This document does not contain any information about acceptance criteria or a study that proves the device meets those criteria.

    Therefore, I cannot fulfill your request for the detailed table and study information as it is not present in the given input.

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