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Orthofix Inc.

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Web: http://www.orthofix.com
E-Mail:
Address: 1720 Bray Central Drive, McKinney, Texas 75069, USA
Phone: +1-(469)-742-2500, 800-535-4492 | Map/Directions >>
 
 

Profile: Orthofix Inc. designs, manufactures & distributes medical equipment, mainly for the orthopedic market. Our orthopedics, spine and sports medicine divisions offer innovative treatment options for adult & pediatric deformity correction, internal & external racture fixation, biologics & bone growth stimulation, interbody fusion, & bracing. Our spine products are categorized as cervical, thoracolumbar, biologics, bone growth stimulation, and interbody fusion. Our Ascent® posterior occipital cervical thoracic system allows surgeons to address complicated fusion cases from the base of the skull to the thoracic region. While the occipital plate enables fixation to the occiput, the detailed engineering of the multi-axial screws and cross connectors simplify the procedure. The multi-axial screws feature 66 degrees of angulation, which minimizes rod contouring. The multi-plane adjustable cross connectors are pre-assembled and utilize a drop-in design for easy insertion. Our Spinal fixation system (SFS) provides simple, reliable and comprehensive stabilization solutions for spinal fixation. It is intended for non-cervical use in the spine.

The company was founded in 1980, has ~200 employees and is ISO certified. NASDAQ:OFIX (SEC Filings)

FDA Registration Number: 2183449

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• PCL Soft Bracing Kit
• Pediatric Orthoses
• Pelvic External Fixators
• Pelvic Traction Belt (FDA Code: HSQ / 888.5890)
A noninvasive traction component is a device, such as a head halter, pelvic belt, or a traction splint, that does not penetrate the skin and is intended to assist in connecting a patient to a traction apparatus so that a therapeutic pulling force may be applied to the patient's body.
• Periarticular Hybrid Fixator
• Pertrochanteric Fixator
• Pneumatic Vest
• Polyhedral Allen Wrench
• Post-operative Elbow Brace
• Posterior Cruciate Ligament Soft Bracing Kit
• Probes (FDA Code: HXB / 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.
• Probes (FDA Code: HXB / 888.4540)
• Prosthesis Driver (FDA Code: HWR / 888.4540)
• Proximal Femoral & Recon Nails
• Radiolucent Bar
• Rib Rongeurs (FDA Code: HTX / 888.4540)
• Ring Connecting Screw
• Ring Fixation System
• Ring Fixator
• Ruler and Caliper (FDA Code: FTY / 878.4800)
A manual surgical instrument for general use is a nonpowered, hand-held, or hand-manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, blood lancet, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892.
• Scalpel Handle (FDA Code: GDZ / 878.4800)
• Screwdriver (FDA Code: HXX / 888.4540)
• Shoulder Abduction Pillow
• Shoulder Soft Bracing Kit
• Shoulder Stabilizer Brace
• Single Screw Clamp
• Slotted Washer
• Socket Pusher (FDA Code: HXO / 888.4540)
• Soft Bracing Kits
• Speed Wrench
• Spinal Fixation Device
• Spinal Interlaminal Fixation Appliance (FDA Code: KWP / 888.3050)
A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.
• Spinal Intervertebral Body Fixation Appliance (FDA Code: KWQ / 888.3060)
A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct "sway back," scoliosis (lateral curvature of the spine), or other conditions.
• Spinal Orthoses
• Spinal Pedicle Fixation Orthosis (FDA Code: MNI / 888.3070)
Pedicle screw spinal systems are multiple component devices, made from a variety of materials, including alloys such as 316L stainless steel, 316LVM stainless steel, 22Cr-13Ni-5Mn stainless steel, Ti-6Al-4V, and unalloyed titanium, that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of anchors (e.g., bolts, hooks, and/or screws); interconnection mechanisms incorporating nuts, screws, sleeves, or bolts; longitudinal members (e.g., plates, rods, and/or plate/rod combinations); and/or transverse connectors.
• Spinal Pedicle Fixation Orthosis For Degenerative Disc Disease (FDA Code: NKB / 888.3070)
• Spinal Vertebral Body Replacement Device (FDA Code: MQP / 888.3060)
• Spondylolisthesis Spinal Fixation Orthosis (FDA Code: MNH / 888.3070)
• Static External Fixators
• Suction Catheter and Tip (FDA Code: JOL / 880.6740)
A vacuum-powered body fluid suction apparatus is a device used to aspirate, remove, or sample body fluids. The device is powered by an external source of vacuum. This generic type of device includes vacuum regulators, vacuum collection bottles, suction catheters and tips, connecting flexible aspirating tubes, rigid suction tips, specimen traps, noninvasive tubing, and suction regulators (with gauge).
• Surgical Curette (FDA Code: FZS / 878.4800)
• Surgical Cutter (FDA Code: FZT / 878.4800)
• Surgical Hammer (FDA Code: FZY / 878.4800)
• Surgical Instrument Tray (FDA Code: FSM / 878.4800)
• Surgical Retractor (FDA Code: GAD / 878.4800)
• Surgical Retractor Systems (FDA Code: GAD / 878.4800)
• Surgical Stylet (FDA Code: GAH / 878.4800)
• Synthetic Bone Graft
• Table Operating Room Accessories (FDA Code: FWZ / 878.4950)
A manual operating table and accessories and a manual operating chair and accessories are nonpowered devices, usually with movable components, intended to be used to support a patient during diagnostic examinations or surgical procedures.
• Tamps (FDA Code: HXG / 888.4540)

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