Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K060151
    Device Name
    ORBITAL TISSUE EXPANDER (OTE)
    Manufacturer
    INNOVIA, LLC
    Date Cleared
    2006-08-08

    (200 days)

    Product Code
    NFM
    Regulation Number
    886.3320
    Why did this record match?
    Product Code :

    NFM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OTE would be used in the case of congenital anophthalmia, congenital microphthalmia or acquired anophthalmia from, e.g., childhood ocular tumors or trauma.
    Device Description
    The integrated orbital tissue expander (OTE), consisting of a flexible "balloon/expander" is held in place by means of a titanium fixation plate that is anchored to the lateral orbital wall by screws. A slotted arm attached to the fixation plate, extends through a slot that is formed within the OTE. The OTE can be manually moved along the shaft of the fixation plate to achieve optimal central position in an expanding socket. A 30 gauge disposable hypodermic needle connected to a 1 cc disposable syringe filled with sterile saline is inserted into the OTE through an injection port. Inflation of the OTE will effect pressure on the orbit of the patient.
    Ask a Question
    K Number
    K010852
    Device Name
    OSMED TISSUE EXPANDER
    Manufacturer
    IOP, INC.
    Date Cleared
    2001-08-13

    (145 days)

    Product Code
    NFM
    Regulation Number
    886.3320
    Why did this record match?
    Product Code :

    NFM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

    Page 1 of 1