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510(k) Data Aggregation

    K Number
    K112499
    Device Name
    BIOMERIX COMPOSITE SURGICAL MESH
    Manufacturer
    BIOMERIX CORPORATION
    Date Cleared
    2011-12-23

    (115 days)

    Product Code
    FTL
    Regulation Number
    878.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIOMERIX CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Biomerix Composite Surgical Mesh is intended for repair and/or reinforcement of soft tissues where weakness exists in plastic and reconstructive surgery.
    Device Description
    Biomerix Composite Surgical Mesh is a non-absorbable porous polymer scaffold (polycarbonate polyurethane urea) incorporating knitted polypropylene monofilament fibers.
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    K Number
    K112567
    Device Name
    BIOMERIX ASSURE
    Manufacturer
    BIOMERIX CORPORATION
    Date Cleared
    2011-12-23

    (112 days)

    Product Code
    FTL
    Regulation Number
    878.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIOMERIX CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Biomerix ASSURE™ is intended for repair and/or reinforcement of soft tissues where weakness exists in plastic and reconstructive surgery. The resorbable protective film minimizes tissue attachment to the device.
    Device Description
    Biomerix ASSURE is a sterile, composite mesh comprised of three layers: 1) a thin sheet of the Biomerix Biomaterial™, 2) a layer of knitted polypropylene monofilament fibers and 3) a resorbable lactide-caprolactone film. The resorbable film separates the permanent mesh from underlying tissues and organ surfaces, and it is designed to minimize the risk of tissue attachment to the device during the wound healing period. ASSURE is provided sterile for single use and is available as individually packaged thin sheets in various shapes and sizes.
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    K Number
    K093123
    Device Name
    BIOMERIX VENTRAL HERNIA REPAIR MESH, MODEL SM3-TAB
    Manufacturer
    BIOMERIX CORPORATION
    Date Cleared
    2010-05-13

    (223 days)

    Product Code
    FTL
    Regulation Number
    878.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIOMERIX CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Biomerix Ventral Hernia Repair Mesh is intended for the reconstruction of hernias and soft tissue deficiencies and for the temporary bridging of fascial defects. The resorbable protective film minimizes tissue attachment to the device in case of direct contact with the viscera.
    Device Description
    The Biomerix Ventral Hernia Repair Mesh is a sterile, composite mesh comprised of three layers: 1) a thin sheet of the Biomerix Biomaterial™, 2) a layer of knitted polypropylene monofilament fibers and 3) a resorbable lactide-caprolactone film. The resorbable film separates the permanent mesh from underlying tissues and organ surfaces, and it is designed to minimize the risk of a tissue attachment to the device during the wound healing period. The Biomerix Ventral Hernia Repair Mesh is provided sterile for single use and is available as individually packaged thin sheets in various shapes and sizes.
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    K Number
    K082941
    Device Name
    BIOMERIX COMPOSITE SURGICAL MESH, MODEL SMNR-0510 AND SMNR-1215
    Manufacturer
    BIOMERIX CORPORATION
    Date Cleared
    2009-01-07

    (97 days)

    Product Code
    FTL
    Regulation Number
    878.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIOMERIX CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Biomerix Composite Surgical Mesh is intended to assist in the repair and/or reinforcement of hernia and other soft tissue defects requiring additional support of a nonabsorbable implant during and after wound healing.
    Device Description
    Biomerix Composite Surgical Mesh is a non-absorbable porous polymer scaffold (polycarbonate polyurethane urea) incorporating knitted polypropylene monofilament fibers.
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    K Number
    K070961
    Device Name
    BIOMERIX SURGICAL MESH, MODEL: RCR-01
    Manufacturer
    BIOMERIX CORPORATION
    Date Cleared
    2008-02-25

    (326 days)

    Product Code
    FTL
    Regulation Number
    878.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIOMERIX CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Biomerix Surgical Mesh is intended for the reinforcement of the soft tissues which are repaired by suture or suture anchors during rotator cuff repair surgery. The mesh is not intended to replace normal body structure or provide full mechanical strength to support the rotator cuff. Sutures used to repair the tear, and sutures or bone anchor systems used to attach the tissue to the bone, provide mechanical strength for tendon repair.
    Device Description
    The Biomerix Surgical Mesh is a non-absorbable mesh manufactured from a polycarbonate polyurethane-urea matrix and standard polyester suture. The Biomerix Surgical Mesh is provided sterile for single use.
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    K Number
    K043371
    Device Name
    BIOMERIX VASCULAR OCCLUSION DEVICE AND LOADER
    Manufacturer
    BIOMERIX CORPORATION
    Date Cleared
    2005-02-03

    (57 days)

    Product Code
    KRD
    Regulation Number
    870.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIOMERIX CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Biomerix Vascular Occlusion Device is intended for arterial and venous embolization in the peripheral vasculature.
    Device Description
    The Biomerix Vascular Occlusion Device is a cylindrical device made from polycarbonate-urethane. The length of the implant is 15 mm, and it is available in diameters of 4, 6, and 8 mm. The Biomerix Vascular Occlusion Device is provided sterile for single use in its uncompressed state. The device is compressed and delivered to the target location through a commercially available peripheral introducer (5-7 F). A Loader is provided to assist with introducing the implant into the delivery catheter.
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