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510(k) Data Aggregation

    K Number
    K163486
    Device Name
    DRACO Locking Bone Screws; DRACO Compression Screws; DRACO MetaFuse L Plates; DRACO MetaFuse BLP Plates; DRACO MetaFuse MTP Plates, Takú Plates, DuoTakú Plates, Open Wedge Plates, Osteoplate Plates, Plantar Plates, Calcaneus Offset Locking Plates
    Manufacturer
    HNM Total Recon, LLC
    Date Cleared
    2017-07-24

    (224 days)

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

    HNM Total Recon, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DRACO Locking Screws are intended to be used in combination with DRACO Locking plates for adult and pediatric patients as indicated for small bone fracture fixations for use include fixation of fractures, osteotomies, nonunions of the clavicle, scapula, olecranon, radius, metacarpals, metatarsals, Hallux Valgus osteotomy corrections, middle hand and middle foot bones, particular in osteopenic bone. The DRACO Compression Screws are indicated for fracture fixation of various bones, including, osteotomies in the foot (as Hallux Valgus treatment) or hand, foot or ankle surgery, fixation of bone fragments in long bones or small bone fractures. The size of the chosen screw should be adapted to the specific indication. The DRACO MetaFuse L Plates and the DRACO MetaFuse BLP Plates are used for adult and pediatric patients as indicated for small bone fracture fixations for use include fixation of fractures, ostectornies, non-unions of the clavicle, scapula, olecranon, radius, ulna, metacarpals, Hallux Valgus osteotomy corrections, middle hand and middle foot bones, particular in osteopenic bone. The DRACO MetaFuse MTP Plates, DuoTakú Plates, Open Wedge Plates, Osteoplate Plates, Plantar Plates, Calcaneus Offset Locking Plates can be used for adult and pediatric patients. Indications for use include fixation of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, feet, wrist, and toes.
    Device Description
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