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510(k) Data Aggregation

    K Number
    K181026
    Device Name
    OsteoBridge™ IDSF System
    Manufacturer
    Date Cleared
    2018-10-17

    (182 days)

    Product Code
    Regulation Number
    888.3020
    Why did this record match?
    Applicant Name (Manufacturer) :

    Merete GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    - Long-term stabilization of major bone defects resulting from o Radical bone loss due to tumors and/or metastases o Bone resections following tumors and/or metastases - For use only in the diaphyseal region of humerus, tibia and femur
    Device Description
    The OsteoBridge™ IDSF System is intended to be used in the management of segmental diaphyseal bone loss secondary to radical bone loss and/or resection due to tumors in either humerus, tibia or femur in oncology patients. The modular system includes a spacer made of two cylindrical half-shells that clamp over the ends of two intramedullary nails with eight screws. Spacers and intramedullary nails of different sizes can be selected to accommodate varying intramedullary canal diameters and different bone defect sizes. If the defect size is larger than 70 mm, two spacers may be connected with a spacer connector. The nails can be used non-cemented. All components of the OsteoBridge™ IDSF System are manufactured from Ti6Al4V ELI titanium alloy according to ASTM F 136.
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    K Number
    K172213
    Device Name
    MECRON Cannulated Screw System
    Manufacturer
    Date Cleared
    2017-10-23

    (91 days)

    Product Code
    Regulation Number
    888.3040
    Why did this record match?
    Applicant Name (Manufacturer) :

    Merete GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The MECRON™ Cannulated Screw System is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, ligament fixation, fracture repair and fracture fixation, appropriate for the device.
    Device Description
    The MECRON™ Cannulated Screw System consists of headed and headless bone screws and corresponding washers. The screws are offered in diameters from 2.0mm thru 7.0mm (in 0.5 mm increments) and overall lengths from 8 mm (for smaller diameters) thru 120 mm (for larger diameters). The cannulated screws have self-tapping and self-drilling features and are manufactured from medical grade titanium alloy (per DIN EN ISO 5832-3 and ASTM F136).
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