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510(k) Data Aggregation

    K Number
    K132830
    Device Name
    DISTALOCK TIBIAL IM NAIL SYSTEM
    Manufacturer
    Date Cleared
    2014-01-06

    (118 days)

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

    DGIMED ORTHO, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Intended to stabilize shaft fractures between the proximal and distal third of the tibia. Indications include transverse, comminuted, spiral, oblique, and segmental fractures. The Tibial Nail may also be used for treatment of mal-unions as well as prophylactic nailings of impending pathological fractures.
    Device Description
    The DGIMED Ortho DISTALOCK™ Tibial Intramedullary Nail System permits an intramedullary approach for fixation of fractures of the tibia: The DISTALOCK™ Tibial Naillis a closed section, cannulated, curved intramedullary fixation device containing four proximal (three static and one dynamic) and three distal holes to accept locking screws which thread transversely though the proximal and distal third of the tibia. The DISTALOCK™ Tibia Intramedullary Nail System includes the following components: DISTALOCK™ Tibial Intramedullary nails, locking screws and end caps made of titanium alloy. The DISTALOCK™ Tibial Ancillary Instrumentation includes the DISTALOCK™ Tibial Drill and other disposable and reusable instruments needed for accessing the tibial medullary canal; preparing the bone for placement and installation of the nail and locking screws, and removal of the nail and locking screws if required.
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    K Number
    K100312
    Device Name
    DISTALOCK FEMORAL INTRAMEDULLARY NAIL SYSTEM
    Manufacturer
    Date Cleared
    2010-04-20

    (75 days)

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

    DGIMED ORTHO, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The DISTALOCK™ Femoral Intramedullary Nail System is indicated for use in orthopedic intramedullary nailing procedures: midline femoral fractures, femoral fractures in multiple trauma patients, fractures in the morbidly obese patient, fractures in osteoporotic bone or malunions and nonunions.
    Device Description
    The DISTALOCK™ Femoral Intramedullary (IM) Nail System permits an antegrade intramedullary approach for fixation of fractures of the femur. The DISTALOCK™ Femoral Intramedullary Nail is a closed section, cannulated, thick walled, mirror finished, curved intramedullary fixation device containing two proximal and two distal holes to accept locking screws which thread transversely though the proximal and distal third of the femur. The DISTALOCK™ Femoral IM Nail System includes the following components: DISTALOCK™ IM standard entry and trochanteric nails, locking screws and end caps made of titanium allov. The DISTALOCK™ Ancillary Instrumentation includes the DISTALOCK™ drill, the DISTALOCK™ Control System (which includes the control box, drill motor assembly and hand controller) and other disposable and reusable instruments.
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    K Number
    K091309
    Device Name
    REVOLUTION FEMORAL INTRAMEDULLARY NAIL SYSTEM, MODEL DGOOXX
    Manufacturer
    Date Cleared
    2009-11-05

    (185 days)

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

    DGIMED ORTHO, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Revolution Femoral Intramedullary Nail System is indicated for use in orthopaedic intramedullary nailing procedures: midline femoral fractures, femoral fractures in multiple trauma patients, fractures in the morbidly obese patient, fractures in osteoporotic bone or malunions and nonunions.
    Device Description
    The Revolution Femoral Intramedullary Nail System permits an antegrade intramedullary approach for fixation of fractures of the femur. The Revolution Femoral Intramedullary Nail is a closed section, cannulated, thick walled, mirror finished, curved intramedullary fixation device containing two proximal and two distal holes to accept locking screws which thread transversely though the proximal and distal third of the femur. The Nail is available in a variety of diameters and lengths. Locking screws are also included as a component of the Nail system. The locking screws are designed to reduce the likelihood of shortening and rotation of femoral fractures. The locking screws are available in a single diameter and a variety of lengths. The ancillary instrumentation include standard orthopedic instruments for accessing the femoral medullary canal, preparing the bone for placement and installation of the intramedullary nail and locking screws, and removal of the intramedullary nail and screws, if required.
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