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510(k) Data Aggregation

    K Number
    K072740
    Device Name
    MONDEAL EXTREMITY BONE FIXATION SYSTEM
    Manufacturer
    MONDEAL MEDICAL SYSTEMS GMBH
    Date Cleared
    2007-11-19

    (53 days)

    Product Code
    HRS
    Regulation Number
    888.3030
    Why did this record match?
    Applicant Name (Manufacturer) :

    MONDEAL MEDICAL SYSTEMS GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K071797
    Device Name
    MONDEAL HAND CONTOUR SYSTEM
    Manufacturer
    MONDEAL MEDICAL SYSTEMS GMBH
    Date Cleared
    2007-09-17

    (77 days)

    Product Code
    HRS
    Regulation Number
    888.3030
    Why did this record match?
    Applicant Name (Manufacturer) :

    MONDEAL MEDICAL SYSTEMS GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Mondeal® HAND CONTOUR System is intended to be used for the internal fixation of small bones including the hand and the foot.
    Device Description
    The Mondeal® Hand Contour System consists of titanium plates with shapes and sizes designed for internal fixation of small bones including the hand and foot, and screws of varying lengths from 4 to 23 mm and 1.2 , 1.7, and 2.3 mm in diameter, supplied nonsterile packaged together in either tempered plastic or stainless steel trays suitable for recommended steam sterilisation, and also individually for single implantable use. The plates include straight, "T" shaped and condylar configurations. Manual reusable surgical instruments are supplied to facilitate implantation
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    K Number
    K071798
    Device Name
    MONDEAL DISTAL RADIUS SYSTEM
    Manufacturer
    MONDEAL MEDICAL SYSTEMS GMBH
    Date Cleared
    2007-09-17

    (77 days)

    Product Code
    HRS
    Regulation Number
    888.3030
    Why did this record match?
    Applicant Name (Manufacturer) :

    MONDEAL MEDICAL SYSTEMS GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Mondeal® DISTAL RADIUS System is intended to be used for the fixation of fractures and osteotomies involving the distal radius applied to the volar and dorsal aspect.
    Device Description
    The Mondeal® Distal Radius System consists of titanium volar and dorsal plates with shapes and sizes designed for internal fixation of distal radius fractures and osteotomies, and screws of varying lengths from 8 to 38 mm and 2.7 or 3.0 mm in diameter, supplied non-sterile packaged together in either tempered plastic or stainless steel trays suitable for recommended steam sterilisation, and also individually for single implantable use. The plates include dorsal and volar "T" shaped right and configurations. Manual reusable surgical instruments may be supplied to facilitate implantation.
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    K Number
    K062436
    Device Name
    SIS SINUS IMPLANT STABILIZER
    Manufacturer
    MONDEAL MEDICAL SYSTEMS GMBH
    Date Cleared
    2007-07-30

    (343 days)

    Product Code
    JEY
    Regulation Number
    872.4760
    Why did this record match?
    Applicant Name (Manufacturer) :

    MONDEAL MEDICAL SYSTEMS GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SIS Sinus Implant Stabilizer is intended to provide a fixed anchorage point to stabilize dental implants in the sinus region, enabling sinus augmentation and implantation to be carried out in one session.
    Device Description
    The SIS Sinus Implant Stabilizer consists of a titanium plate provided with 3 large perforations for screw fixation of implants for premolars and first molars. It may be additionally secured in place with titanium microscrews and is provided in two sizes for use with different implant systems.
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    K Number
    K050257
    Device Name
    LIN/LIOU ORTHODONTIC MINI ANCHOR SYSTEM (LOMAS) (STERILE)
    Manufacturer
    MONDEAL MEDICAL SYSTEMS GMBH
    Date Cleared
    2005-02-07

    (4 days)

    Product Code
    DZE
    Regulation Number
    872.3640
    Why did this record match?
    Applicant Name (Manufacturer) :

    MONDEAL MEDICAL SYSTEMS GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Lin/Liou Orthodontic Mini Anchor System (LOMAS) (Sterile) is intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. The device is used temporarily and is removed after orthodontic treatment has been completed. Screws are intended for single use only.
    Device Description
    Not Found
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    K Number
    K042345
    Device Name
    LIN/LIOU ORTHODONTIC MINI ANCHOR SYSTEM (LOMAS)
    Manufacturer
    MONDEAL MEDICAL SYSTEMS GMBH
    Date Cleared
    2005-01-13

    (136 days)

    Product Code
    DZE
    Regulation Number
    872.3640
    Why did this record match?
    Applicant Name (Manufacturer) :

    MONDEAL MEDICAL SYSTEMS GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Lin/Liou Orthodontic Mini Anchor System (LOMAS) is intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. The device is used temporarily and is removed after orthodontic treatment has been completed. Screws are intended for single use only
    Device Description
    Lin/Liou Orthodontic Mini Anchor System (LOMAS)
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