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Orthofix Srl


Web: http://www.orthofix.it
Address: Via Delle Nazioni 9, Bussolengo 37012, Italy
Phone: +39-(45)-6719000 | Fax: +39-(45)-6719370 | Map/Directions >>
 
 

Profile: Orthofix Srl designs, develops, manufactures & distributes orthopedic products for the spine, reconstruction and trauma. We offer a wide range of minimally invasive surgical and non surgical products. Our external fixator Xcaliber is comfortable for the patient, while maintaining the stability and strength of a traditional fixative.

FDA Registration Number: 9680825
US Agent: Kimberley Elting / Orthofix Inc.
Phone: +1-(214)-937-2000  E-Mail:

11 Products/Services (Click for related suppliers)  
• Bone Fixation Nail (FDA Code: JDS / 888.3030)
Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.
• Bone Fixation Plate (FDA Code: HRS / 888.3030)
• Intramedullary Fixation Rod and Accessories (FDA Code: HSB / 888.3020)
An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.
• Invasive Traction Component (FDA Code: JEC / 888.3040)
A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.
• Non-Powered Traction Apparatus (FDA Code: HST / 888.5850)
A nonpowered orthopedic traction apparatus is a device that consists of a rigid frame with nonpowered traction accessories, such as cords, pulleys, or weights, and that is intended to apply a therapeutic pulling force to the skeletal system.
• Orthopedic Manual Surgical Instrument (FDA Code: LXH / 888.4540)
An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery. This generic type of device includes the cerclage applier, awl, bender, drill brace, broach, burr, corkscrew, countersink, pin crimper, wire cutter, prosthesis driver, extractor, file, fork, needle holder, impactor, bending or contouring instrument, compression instrument, passer, socket positioner, probe, femoral neck punch, socket pusher, reamer, rongeur, scissors, screwdriver, bone skid, staple driver, bone screw starter, surgical stripper, tamp, bone tap, trephine, wire twister, and wrench.
• Proximal Femoral Fixation Implant Device (FDA Code: JDO / 888.3030)
• Reamer (FDA Code: HTO / 888.4540)
• Single Component Fixation Appliance (FDA Code: KTW / 888.3030)
• Templates (FDA Code: HWT / 888.4800)
A template for clinical use is a device that consists of a pattern or guide intended for medical purposes, such as selecting or positioning orthopedic implants or guiding the marking of tissue before cutting.
• Threaded Fixation Pin (FDA Code: JDW / 888.3040)

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