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510(k) Data Aggregation

    K Number
    K140625
    Device Name
    ORTHOSORB LS
    Manufacturer
    BIOMET, INC.
    Date Cleared
    2014-04-18

    (38 days)

    Product Code
    OVZ
    Regulation Number
    888.3040
    Why did this record match?
    Product Code :

    OVZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    1.) To fix in place small bony or chondral fragments in the knee and hand where such fragments are not in tension, as in the case of osteochondritis dissecans or fractures of the phalanges and metacarpals; 2.) For fixation of inherently stable osteotomies of the great toe and first metatarsal and intramedullary stabilization of joint arthroplasty (resection) for the treatment of lesser toe deformities. 3.) Used to provide additional support in cases of finger joint fusion and digit replantation where standard fixation or support techniques are also employed.
    Device Description
    Biomet OrthoSorb LS resorbable fixation devices include straight and tapered pins. Biomet OrthoSorb LS resorbable fixation devices are made of a resorbable copolymer, polyester derivative of L-lactic and glycolic acids. Poly L-lactic/polyglycolic acid copolymer degrades and resorbs in-vivo by hydrolysis into L-lactic and glycolic acids which are then metabolized by the body.
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    K Number
    K111077
    Device Name
    ORTHOSORB RESORBABLE PINS
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Date Cleared
    2011-07-12

    (85 days)

    Product Code
    OVZ
    Regulation Number
    888.3040
    Why did this record match?
    Product Code :

    OVZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ORTHOSORB Resorbable pin are indicated for use to fix in place small bony or chondral fragments in the knee and hand where such fragments are not in tension, as in the case of osteochondritis dissecans or fractures of the phalanges and metacarpals; or for fixation of inherently stable osteotomies of the great toe and intramedullary stability of joint arthroplasty (resection) for the treatment of lesser toe deformities. The Resorbable Pin can be used to provide additional support in cases of finger joint fusion and digit replantation where standard fixation or support techniques are also employed.
    Device Description
    The ORTHOSORB 1.3mm and 2.0mm Resorbable Pins are made from poly-p-dioxanone and are available in 1.3mm and 2.0mm diameters and 40mm and 50mm lengths with their accompanying instrumentation.
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