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510(k) Data Aggregation

    K Number
    K972143
    Device Name
    MOA BONE / M-SPHERE
    Manufacturer
    IOP, INC.
    Date Cleared
    1997-10-16

    (132 days)

    Product Code
    HPZ
    Regulation Number
    886.3320
    Type
    Traditional
    Panel
    Ophthalmic
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MOA BONE / M-SPHERE

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

    Hydroxyapitate orbital implants are indicated for post enucleation patients. This product is intended to establish a platform to affix an artificial eye that becomes integrated with the patients tissues.

    Device Description

    Moa Bone™ - Hydroxyapitate Orbital Implant

    AI/ML Overview

    This document is a 510(k) premarket notification letter from the FDA for a medical device called "Moa Bone™ - Hydroxyapatite Orbital Implant." It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The letter primarily addresses the substantial equivalence determination for marketing the device.

    Therefore, I cannot provide the requested information based on the provided text.

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