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510(k) Data Aggregation

    K Number
    K102597
    Device Name
    PICCOLO COMPOSITE PLATE SYSTEM
    Manufacturer
    N.M.B. MEDICAL APPLICATIONS, LTD.
    Date Cleared
    2011-02-24

    (167 days)

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

    N.M.B. MEDICAL APPLICATIONS, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Piccolo Composite™ Diaphyseal Plate: The Piccolo Composite™ Diaphyseal Plate is indicated for the fixation of various long bones, such as the humerus, femur and tibia, including osteopenic bone, osteotomies, and nonunions or malunions in adult patients. These plates are also indicated for fracture fixation of diaphyseal areas of long bones in pediatric patients. Piccolo Composite™ Proximal Humerus Plate: The Piccolo Composite™ Proximal Humerus Plate is indicated for fractures, fracture dislocations, osteotomies, and nonunions of the proximal humerus, including in osteopenic bone. Piccolo Composite™ Distal Volar Radius Plate: The Piccolo Composite™ Distal Volar Radius Plate is indicated for fractures and osteotomies of the distal volar radius.
    Device Description
    The Piccolo Composite Plate System comprises implants (plates and screws/pegs), and a set of instruments. The Plates are made of carbon fiber reinforced polyetheretherketone (CFR-PEEK), and are marked with a tantalum thread, to provide for their visualization under fluoroscopy. The following types of plates are available: Diaphyseal Plates (thickness: 4.5 mm or 5 mm); Proximal Humerus Plate (thickness: 3.7 mm); Distal Volar Radius Plate (thickness: 2.4 mm). The Screws (and Pegs) are made of titanium alloy. Various screw types are available, such as cortical screws and locking screws, as well as pegs (to be used only with the Distal Radius Plate), in various dimensions.
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    K Number
    K102369
    Device Name
    PICCOLO COMPOSITE NAILING SYSTEM
    Manufacturer
    N.M.B. MEDICAL APPLICATIONS, LTD.
    Date Cleared
    2011-01-31

    (164 days)

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

    N.M.B. MEDICAL APPLICATIONS, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Indications for the Piccolo Composite Tibial and Femoral Nails include simple fractures; severely comminuted, spiral, large oblique and segmental fractures; nonunions and malunions; polytrauma and multiple fractures; prophylactic nailing of impending pathological fractures; reconstruction, following tumor resection and grafting. The Piccolo Composite Tibial and Femoral Nails are indicated for fixation of fractures that occur in and between the proximal and distal third of the long bones being treated.
    Device Description
    The Piccolo Composite Nailing System includes nails, interlocking screws and a set of instruments. The Piccolo Composite Nail indicated for treatment of the tibia and femur is a cannulated, cylindrical rod, made of carbon fiber reinforced polymer. The tibial nail diameter ranges from 9 to 11 mm, with lengths in the range of 260 to 380 mm; the femoral nail diameter ranges from 10 to 12 mm, with lengths in the range of 300 to 420 mm. The nails provide for holes at the proximal and distal sections, designed for the insertion of titanium-alloy-made screws. The nail has a pointed distal end and incorporates a thread enabling connection of insertion/extraction instrumentation.
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    K Number
    K100497
    Device Name
    QUANTUM IM COMPOSITE NAILING SYSTEM (QUANTUM NAILING SYSTEM)
    Manufacturer
    N.M.B. MEDICAL APPLICATIONS, LTD.
    Date Cleared
    2010-06-21

    (119 days)

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

    N.M.B. MEDICAL APPLICATIONS, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Indications for the Piccolo Composite Humeral Nail and Proximal Humerus Nail include simple humeral fractures; severely comminuted, spiral, large oblique and segmental fractures; nonunions and malunions; polytrauma and multiple fractures; prophylactic nailing of impending pathological fractures; reconstruction, following tumor resection and grafting. The Piccolo Composite Humeral and Proximal Humerus Nails are indicated for fixation of fractures that occur in and between the proximal and distal third of the humerus.
    Device Description
    The Piccolo Composite Nailing System includes humeral and proximal humerus nails. interlocking screws and a set of instruments. The Piccolo Composite Nail is a cylindrical solid rod, made of carbon fiber reinforced polymer. The humeral nail diameter ranges from 7 mm to 8.5 mm, with lengths in the range of 180 mm to 280 mm. The dimensions of the proximal humerus nail are 8 mm diameter (11 mm at proximal end), and length of 150 mm. The nails provide for holes at proximal and distal sections, designed for the insertion of self-tapping, titanium-allovmade, interlocking screws. The nails have a closed, pointed distal end, and their proximal end incorporates a thread enabling connection of insertion/extraction instrumentation.
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    K Number
    K091425
    Device Name
    QUANTUM M COMPOSITE NAILING SYSTEM
    Manufacturer
    N.M.B. MEDICAL APPLICATIONS, LTD.
    Date Cleared
    2010-01-21

    (253 days)

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

    N.M.B. MEDICAL APPLICATIONS, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Indications for the Quantum IM Composite Humeral Nail include simple humeral fractures; severely comminuted, spiral, large oblique and segmental fractures; nonunions and malunions; polytrauma and multiple fractures; prophylactic nailing of impending pathological fractures; reconstruction, following tumor resection and grafting. The Quantum IM Composite Humeral Nail is indicated for fixation of fractures that occur in and between the proximal and distal third of the humerus.
    Device Description
    The Quantum IM Composite Nailing System includes nails, interlocking screws and a set of instruments. The Quantum IM Composite Nail is a cylindrical solid rod, made of carbon fiber reinforced polymer. Its diameter ranges from 7 to 8.5 mm, with lengths in the range of 180 to 280 mm. The nail provides for holes at its proximal and distal sections, designed for the insertion of the 3.5 mm self-tapping, cortical, titanium-alloy-made, interlocking screws. The nail has a closed, pointed distal end, and its proximal end incorporates a thread enabling connection of insertion/extraction instrumentation.
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