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510(k) Data Aggregation

    K Number
    K241253
    Device Name
    Medicon Epiplating System
    Manufacturer
    CMF Medicon Surgical Inc.
    Date Cleared
    2024-12-12

    (223 days)

    Product Code
    FZE
    Regulation Number
    878.3680
    Why did this record match?
    Applicant Name (Manufacturer) :

    CMF Medicon Surgical Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Medicon Epiplating System is indicated for the attachment of an external restoration prosthesis for restoration of a physical defect when other means of attachment are inadequate. The Epiplating system provides the bone anchorage for the prosthetic attachment. These devices are indicated for use in the maxillo-craniofacial region (including ear, nose and eye).
    Device Description
    The Medicon Epiplating System is an implant system consisting of various plates used as the foundation for anchoring prostheses or epitheses in the craniofacial region. The system offers various implant sizes to fit the anatomical needs of a wide variety of patients. Components are manufactured from pure titanium (ASTM F67) or Ti6Al4V alloy (ASTM F136).
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    K Number
    K212126
    Device Name
    MediExpand Cervical Expandable VBR System
    Manufacturer
    CMF Medicon Surgical Inc.
    Date Cleared
    2022-04-04

    (271 days)

    Product Code
    PLR
    Regulation Number
    888.3060
    Why did this record match?
    Applicant Name (Manufacturer) :

    CMF Medicon Surgical Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MediExpand Cervical Expandable VBR System is intended for use in the cervical spine (C3-C7 vertebral bodies) in skeletally mature patients to replace a diseased or damaged vertebral body caused by tumor, fracture, or osteomyelitis, or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. Use of the MediExpand Cervical Expandable VBR System is limited to single-level or two-level corpectomy and the device is intended to be used with supplemental fixation cleared by the FDA for use in the cervical spine. These implants are intended for use with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, as an adjunct to fusion. The MediExpand Cervical Expandable VBR System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited period of time in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.
    Device Description
    The MediExpand Cervical Expandable VBR System is an adjustable vertebral body replacement device that is implanted into the vertebral body space to improve stability of the spine. The system comprises of vertebral body devices of various heights, sizes and footplates to fit the anatomical needs of a wide variety of patients. The devices can be adjusted to the required height after implantation. Once it is adjusted to the desired height the device is mechanically locked in place with fixation screws. The devices have a rectangular space to allow grafting material to be packed inside the devices. Spikes on the footplates improve the anchoring of the implant to the vertebral body. The footplates are available in various lordotic anqles. The devices have threaded holes for anchor screws which can be inserted into the adjacent vertebral bodies. Components are manufactured from titanium alloy (Ti6Al4V) per ASTM F-136 and ISO 5832-3.
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    K Number
    K190349
    Device Name
    MediExpand TL Expandable VBR System
    Manufacturer
    CMF Medicon Surgical Inc.
    Date Cleared
    2019-10-24

    (252 days)

    Product Code
    MQP
    Regulation Number
    888.3060
    Why did this record match?
    Applicant Name (Manufacturer) :

    CMF Medicon Surgical Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MediExpand TL Expandable VBR System is a vertebral body replacement device indicated for use in the thoracolumbar spine (T1 to L5) to replace a diseased or damaged vertebral body caused by tumor or fracture, to restore the height of a collapsed vertebral body, and to achieve decompression of the spinal cord and neutral tissues. The MediExpand TL Expandable VBR System is intended to be used with supplemental internal spinal fixations systems that are cleared by the FDA for use in the thoracic and lumbar spine. Allograft material may be used at the surgeon's discretion.
    Device Description
    The MediExpand TL Expandable VBR System is an adjustable vertebral body replacement device that is implanted into the vertebral body space to improve stability of the spine. The system comprises of vertebral body devices of various heights, sizes and footplates to fit the anatomical needs of a wide variety of patients. The columns can of the device can be adjusted to the exact length required by the patient's anatomy after implantation. Once it is adjusted to the desired length the columns are mechanically locked in place. The devices have a cylindrical space to allow grafting material to be packed inside the devices. Spikes on the footplates improve the anchoring of the implant to the vertebral body. The footplates are available in various lordotic angles. Components are manufactured from titanium alloy (Ti6Al4V) per ASTM F-136 and ISO 5832-3.
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