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510(k) Data Aggregation

    K Number
    K181843
    Device Name
    MLP Special Locking Bone Plate System
    Manufacturer
    Maxxion Medical, LLC / Baumer SA
    Date Cleared
    2019-03-04

    (236 days)

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

    Maxxion Medical, LLC / Baumer SA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The MLP Special Locking Bone Plate System is indicated for use in internal fixation for bone fractures, fusions, osteotomies, pseudoarthroses, and non-unions of the humerus, radius, ulna, tibia, scapula, clavicle, fibula, tarsal, metatarsal and metatarsophalangeal in pediatrics and adult populations.
    Device Description
    The MLP Special Locking Bone Plate System consists of Bone Plates and locking screw components that are intended to be used in various bone fixation procedures. The MLP Special Locking Bone Plate System consists of bone plates and screws for fractures, fusions, and osteotomies. The bone plates are pre-bent to minimize bending which is done intraoperatively. Instruments are supplied with the implants to aid in the insertion of the plates and screws. All plates and screws are manufactured from titanium (Ti-6Al-4V) in conformance with ASTM F136. Plates and screws are provided non-sterile.
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