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510(k) Data Aggregation

    K Number
    K980140
    Device Name
    SPECTRUM DESIGNS MEDIAL MALAR IMPLANT
    Manufacturer
    SPECTRUM DESIGNS, INC.
    Date Cleared
    1998-03-03

    (47 days)

    Product Code
    LZK
    Regulation Number
    878.3550
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SPECTRUM DESIGNS MEDIAL MALAR IMPLANT

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

    The Spectrum Designs Medial Malar Implant is intended to augment or reconstruct the malar region of the face.

    Device Description

    Spectrum Designs Medial Malar Implant is manufactured from solid silicone elastomer. The implant is implanted in a pocket created by the surgeon in the malar-zygomatic region of the facial skeleton to augment the existing facial structure.

    AI/ML Overview

    This document is a 510(k) summary for the Spectrum Designs Medial Malar Implant. It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.

    The purpose of a 510(k) submission is to demonstrate substantial equivalence to a predicate device, not necessarily to prove the device meets specific performance acceptance criteria through a dedicated study. This document outlines the device description, indications for use, contraindications, and warnings related to the implant. It also identifies substantially equivalent devices.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as this information is not present in the provided text.

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