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510(k) Data Aggregation

    K Number
    DEN220030
    Device Name
    RemeOs™ Screw LAG Solid
    Manufacturer
    Bioretec Ltd.
    Date Cleared
    2023-03-29

    (329 days)

    Product Code
    QJD
    Regulation Number
    888.3041
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    RemeOs™ Screw LAG Solid is intended for the use in traumatic and orthopedic surgery for the fixation of bone fractures (osteosynthesis) and for the fixation after osteotomies, e.g., for the correction of deformities or malalignments. The absorbable implants serve as temporary fixation and stabilization by osteosynthesis of bone fractures and osteotomies until bony fusion has occurred. The RemeOs™ Screw LAG Solid is intended to be used for skeletally mature adults. The RemeOs™ Screw LAG Solid is indicated for the fixation of the medial malleolus.
    Device Description
    The RemeOs™ Screw LAG Solid is an absorbable metallic bone fixation fastener. The product is manufactured from an absorbable magnesium-based alloy containing magnesium, zinc (0.55% (w/w)) and calcium (0.45% (w/w)). The material corrodes under physiological conditions into magnesium, calcium and zinc oxides and hydroxides, while producing hydrogen gas as byproduct. The implant serves as temporary fixation and stabilization by osteosynthesis of bones and fragments until bonv fusion has occurred. The RemeOs™ Screw LAG Solid is provided in one design (Figure 1). The RemeOs™ Screw LAG Solid is a partially threaded solid headed screw with a diameter of 3.5 mm and is offered from lengths 24 to 40 mm in 2 mm increments.
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