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510(k) Data Aggregation

    K Number
    K040199
    Device Name
    OSSE-LIGN, 1.5MM COCR AND SS CABLE SYSTEM AND COMPONENTS
    Manufacturer
    OSSEUS, LLC
    Date Cleared
    2004-02-20

    (22 days)

    Product Code
    JDQ
    Regulation Number
    888.3010
    Why did this record match?
    Applicant Name (Manufacturer) :

    OSSEUS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Osse-Lign System is indicated for general orthopedic repairs. This includes such procedures as long bone fractures, bone grafting and reinforcement of bone. This system may also be used for supplementary fixation and reduction with approved bone plates, screws, pins, nails and bone grafting material. Long Bone Fractures - . Femur fractures - Tibia fractures . - l lumerus fractures l Joint Fractures - 트 Ankle fractures - Knee Fractures 트 - Hip Fractures 비 - . Shoulder Fractures - Elbow Fractures Other bone fractures - 발 Olecranon - Pelvis fractures . - Patella fractures ■ - . Acetabular fractures - Trocanteric reattachment . - Fixation of fractures in conjunction with I/M nailing and plating techniques - Stabilization of cortical onlay strut graft - Temporary reduction techniques for ORIF (Open Reduction Internal Fixation)
    Device Description
    Metallic Internal Fixation Device
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    K Number
    K023564
    Device Name
    OSSE-LIGN
    Manufacturer
    OSSEUS, LLC
    Date Cleared
    2003-03-11

    (139 days)

    Product Code
    JDQ
    Regulation Number
    888.3010
    Why did this record match?
    Applicant Name (Manufacturer) :

    OSSEUS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Osse-Lign System is indicated for general orthopedic repairs. This includes such procedures as long bone fractures, bone grafting and reinforcement of bone. This system may also be used for supplementary fixation and reduction with approved bone plates, screws, pins, nails and bone grafting material. Long Bone Fractures - Femur fractures - Tibia fractures - Humerus fractures Joint Fractures - Ankle fractures - Knee Fractures - Hip Fractures - Shoulder Fractures - Elbow Fractures Other bone fractures - Olecranon - Pelvis fractures - Patella fractures - Acetabular fractures - Trocanteric reattachment - Fixation of fractures in conjunction with I/M nailing and plating techniques - Stabilization of cortical onlay strut graft - Temporary reduction techniques for ORIF (Open Reduction Internal Fixation)
    Device Description
    The Osse-Lign system incorporates cables that are similar in form and material to existing cable systems. However, the Osse-Lign system incorporates a unique set of tools, cable attachments and surgical approaches that permit the surgeon to achieve fracture compression and fixation either without completely encircling the bone or with a minimally invasive cerclage technique. Insertion of the Osse-Lign cables through minimally invasive surgical approaches is made possible by the unique implants and instrumentation. Finally, the in line cable fixation capability permits the use of cables through, rather than around fractures thereby increasing the possible indications for cables in fracture fixation. Implants: The Osse-Lign system comprises implants and instruments designed to permit the insertion, tensioning, crimping and cutting of cables without the need for cerclage or large incisions. The outer diameter of the cable is 2 millimeters (2mm). The cable and all implants are manufactured from certified medical implant grade 316LVM (Low Carbon, Vacuum Melt) Stainless Steel. Cables have fittings mechanically swaged or crimped onto the ends of the cable in the factory setting using power-crimping tools. Instruments: The Osse-Lign System instrumentation consists of the following reusable manual orthopedic instruments: Crimping Tool, Cutting Tool, Tensioning Tool, Flip Anchor Insertion Tool/Cable Passer.
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