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510(k) Data Aggregation

    K Number
    K140644
    Device Name
    PROCEM
    Manufacturer
    OTOTRONIX, LLC
    Date Cleared
    2014-06-19

    (98 days)

    Product Code
    NEA
    Regulation Number
    872.3275
    Why did this record match?
    Product Code :

    NEA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ProCem™ is intended for non-weight bearing applications in Otologic surgery, such as: 1. Reconstruction of ossicular bones or mechanical coupling of the ossicular chain. 2. Mechanical stabilization of middle ear and cochlear implants. 3. Attachment of middle ear implants to the ossicular bones.
    Device Description
    ProCem™ is glass ionomer cement that is provided as two components, a glass powder and polyacrylic acid liquid. By mixing the two components, viscous moldable ionomeric cement is obtained which hardens in situ. ProCem™ is provided in a sterile capsule. The capsule includes the two separate components, a glass powder and polyacrylic acid liquid. An activator is used to release the liquid component prior to use. The capsule is then placed in a mixer, which mixes the glass powder and polyacrylic acid liquid to form a compliant cement. The applicator is used to apply the compliant cement to the appropriate location in the middle ear. The cement then hardens in place to provide a permanent bond.
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    K Number
    K080032
    Device Name
    ENVOYCEM, MODEL 1640
    Manufacturer
    ENVOY MEDICAL CORPORATION
    Date Cleared
    2008-02-28

    (52 days)

    Product Code
    NEA
    Regulation Number
    872.3275
    Why did this record match?
    Product Code :

    NEA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    EnvoyCem is intended for use in otologic surgery for the following applications: - Augmentation or coupling of the middle ear ossicles. - Attachment of the middle ear ossicles to middle ear implants. - Mechanical stabilization of middle ear prostheses.
    Device Description
    EnvoyCem is glass ionomer cement that is provided as two components, a glass powder and polyalkenoic acid liquid. By mixing the two components, viscous moldable ionomeric cement is obtained which hardens in situ.
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    K Number
    K060750
    Device Name
    STRYKER INJECTABLE CEMENT
    Manufacturer
    STRYKER CMF
    Date Cleared
    2006-04-19

    (29 days)

    Product Code
    NEA
    Regulation Number
    872.3275
    Why did this record match?
    Product Code :

    NEA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Stryker® Injectable Cement is indicated for use in the following: augmentation or coupling of the middle ear ossicles, attachment of the middle ear ossicles to middle ear implants, mechanical stabilization of middle ear prostheses, and the reconstruction of the posterior canal wall.
    Device Description
    Hydroxyapatite Cement. Powder and liquid mixed to form a paste for application. Injectable Cement. Calcium Phosphate material. Sterile.
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    K Number
    K042516
    Device Name
    OTOMIMIX
    Manufacturer
    WALTER LORENZ SURGICAL, INC.
    Date Cleared
    2004-11-08

    (53 days)

    Product Code
    NEA
    Regulation Number
    872.3275
    Why did this record match?
    Product Code :

    NEA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    OtoMimix™ is indicated for the following: 1. Augmentation or coupling of the middle ear ossicles. 2. Attachment of the middle ear ossicles to middle ear implants. 3. Mechanical stabilization of middle ear prostheses 4. Reconstruction of the posterior canal wall
    Device Description
    OtoMimix™ is a sterile calcium phosphate Bone Replacement product. When mixed with a stering solution, it becomes moldable material for use in otology procedures. With time, this moldable filler material hardens.
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    K Number
    K011338
    Device Name
    OTO-CEM
    Manufacturer
    OTOTECH, INC.
    Date Cleared
    2001-09-13

    (134 days)

    Product Code
    NEA
    Regulation Number
    872.3275
    Why did this record match?
    Product Code :

    NEA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K003567
    Device Name
    SERENOCEM, MODEL BC 010
    Manufacturer
    CORINTHIAN MEDICAL LTD.
    Date Cleared
    2001-02-12

    (84 days)

    Product Code
    NEA
    Regulation Number
    872.3275
    Why did this record match?
    Product Code :

    NEA

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

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