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510(k) Data Aggregation

    K Number
    K021419
    Device Name
    AART MALAR IMPLANT
    Manufacturer
    AESTHETIC AND RECONSTRUCTIVE TECHNOLOGIES, INC.
    Date Cleared
    2002-07-02

    (60 days)

    Product Code
    LZK
    Regulation Number
    878.3550
    Why did this record match?
    Product Code :

    LZK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the AART Malar Implant is for augmentation or reconstruction of the check areas of the face.
    Device Description
    The AART Malar Implants are manufactured from a medical grade silicone elastomer that has been molded into various crescent shaped concave convex implants. They are provided in four styles in pairs of right and left mirror images with dimensions varying in length, width, and height. The AART Malar Implants are intended to be used for augmentation and reconstruction of the cheek areas of the face. The surface characteristic of the implants is smooth, The AART Malar Implants will be offered sterile and non-sterile.
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    K Number
    K002886
    Device Name
    IMPLANTECH COMPOSITE FACIAL IMPLANTS (MALAR, CHIN, AND NASAL)
    Manufacturer
    IMPLANTECH ASSOCIATES, INC.
    Date Cleared
    2000-11-24

    (70 days)

    Product Code
    LZK
    Regulation Number
    878.3550
    Why did this record match?
    Product Code :

    LZK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K992240
    Device Name
    PILLAR MALAR IMPLANT
    Manufacturer
    PILLAR SURGICAL, INC.
    Date Cleared
    1999-11-22

    (143 days)

    Product Code
    LZK
    Regulation Number
    878.3550
    Why did this record match?
    Product Code :

    LZK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Each Pillar Malar Implant is indicated for the augmentation or reconstruction of malar eminence deficiencies, whether congenital or acquired by trauma or disease.
    Device Description
    The Pillar Malar Implant is made from identical liquid elastomer materials and manufacturing processes as the predicate device. The physical properties of this device are the same as the predicate device in that equivalent materials will be used in manufacturing. The raw materials are Nusil's MED 4211 unrestricted silicone fluid from Nusil Technologies, Inc. The durometers or hardness (shore A) of each implant will range from 5 to 30. The appearance is described as clear to opaque. Tensile strength averages 700 psi and the percent of elongation is over 400 percent.
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    K Number
    K983756
    Device Name
    SURGIFORM ANATOMICAL MALAR
    Manufacturer
    SURGICAL TECHNOLOGY LABORATORIES, INC.
    Date Cleared
    1998-11-20

    (29 days)

    Product Code
    LZK
    Regulation Number
    878.3550
    Why did this record match?
    Product Code :

    LZK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Surgiform Anatomical Malar implants can be used by surgeons in a unique surgical procedure designed to restore or enhance a patients facial appearance. The implants can be used for aesthetic or reconstructive procedures. The implants can be inserted into a "pocket" created by means of a standard intraoral surgical incision. The implants can elevate and reposition sagging skin and can also fill the hollows and depressions caused by gravity and time. The implants can also be used by surgeons to restore a patients natural appearance as a result of severe facial trauma.
    Device Description
    Not Found
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    K Number
    K982763
    Device Name
    SEARE BIOMEDICAL MALAR IMPLANTS
    Manufacturer
    SEARE BIOMEDICAL CORP.
    Date Cleared
    1998-09-30

    (55 days)

    Product Code
    LZK
    Regulation Number
    878.3550
    Why did this record match?
    Product Code :

    LZK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Seare Biomedical Malar Implants are intended to be used to augment or reconstruct the maxilla for cosmetic or reconstructive surgery.
    Device Description
    Seare Biomedical Malar implants are crescent shaped convex silicone elastomer rubber implants made from specially formulated silicone elastomers designed for implantation. They are manufactured in pairs with a mirror image left and right. Surface characteristics will varying degrees of texturing and porosity. Seare Biomedical Malar Implants are intended to be used to augment or reconstruct the maxilla for cosmetic or reconstructive surgery. The Seare Biomedical Malar Implants will be produced using standard manufacturing molding techniques. The Searc Biomedical Malar Implants will be available in many sizes and styles, all of which are very similar - differing only by a few millimeters in length and projection. The Searc Biomedical Malar Implants will be provided sterile and nonsterile.
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    K Number
    K981835
    Device Name
    SILIMED MALAR IMPLANT
    Manufacturer
    SILIMED, LLC.
    Date Cleared
    1998-07-09

    (44 days)

    Product Code
    LZK
    Regulation Number
    878.3550
    Why did this record match?
    Product Code :

    LZK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Silimed Malar Implant is designed to be used for augmentation and reconstruction of the cheek.
    Device Description
    Not Found
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    K Number
    K980139
    Device Name
    SPECTRUM DESIGNS PROFILE MALAR IMPLANT
    Manufacturer
    SPECTRUM DESIGNS, INC.
    Date Cleared
    1998-03-03

    (47 days)

    Product Code
    LZK
    Regulation Number
    878.3550
    Why did this record match?
    Product Code :

    LZK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Spectrum Designs Profile Malar Implant is intended to augment or reconstruct the malar region of the face.
    Device Description
    Spectrum Designs Profile 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.
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    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
    Why did this record match?
    Product Code :

    LZK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    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.
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    K Number
    K980141
    Device Name
    SPECTRUM DESIGNS PROJECTION MALAR IMPLANT
    Manufacturer
    SPECTRUM DESIGNS, INC.
    Date Cleared
    1998-03-03

    (47 days)

    Product Code
    LZK
    Regulation Number
    878.3550
    Why did this record match?
    Product Code :

    LZK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Spectrum Designs Projection Malar Implant is intended to augment or reconstruct the malar region of the face.
    Device Description
    Spectrum Designs Projection 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.
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    K Number
    K973502
    Device Name
    IMPLANTECH CONFORM BINDER SUBMALAR IMPLANT
    Manufacturer
    IMPLANTECH ASSOCIATES, INC.
    Date Cleared
    1997-11-07

    (52 days)

    Product Code
    LZK
    Regulation Number
    878.3550
    Why did this record match?
    Product Code :

    LZK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Implantech Conform™ Combined Submalar® Implant is indicated for implantation to augment or reconstruct the underdeveloped or traumatized malar region of the face. The soft, flexible Conform Combined Submalar Implant is designed to easily conform to the facial skeleton in the malar area.
    Device Description
    The soft, flexible Conform Combined Submalar Implant is designed to easily conform to the facial skeleton in the malar area.
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