Profile: Depuy Spine, Inc. designs, manufactures and sells orthopaedic devices & supplies. Our Devex™ System is indicated for use in the thoracolumbar spine to replace a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord & neural tissues and to restore the height of a collapsed vertebral body. Our Summit™ SI OCT system offers a comprehensive solution for rigid posterior fixation of the occipito-cervicothoracic regions of the spine. Our Symphony™ II Platelet Concentrate System is a point-of-care system designed for the rapid preparation of Platelet Concentrate. It concentrates the body's natural growth factors, which are found in the platelets & it can be mixed with autograft and allograft bone grafting materials prior to application to an orthopedic surgical site as deemed necessary by the clinical use requirements and also produces autologous platelet concentrate containing viable platelets with a full compliment of associated growth factors.
The company was founded in 1895. NYSE:DPU (SEC Filings)
FDA Registration Number: 1526439
• Forceps (FDA Code: HTD / 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. |
• General & Plastic Surgery Surgical Cannula (FDA Code: GEA / 878.4800) |
• General & Plastic Surgery Surgical Elevator (FDA Code: GEG / 878.4800) |
• Graft Chambers |
• Graft Preparation Device |
• Guiding Probes |
• Hook, Screw and Rod Systems |
• Instrument Surgical Guide (FDA Code: FZX / 878.4800) |
• Instruments |
• Intervertebral Disc Prosthesis (FDA Code: MJO) |
• 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. |
• Labeled Medical Laboratory Equipment (FDA Code: LXG / 862.2050) General purpose laboratory equipment labeled or promoted for a specific medical use is a device that is intended to prepare or examine specimens from the human body and that is labeled or promoted for a specific medical use. |
• Laparoscopic Probes |
• Laser Power Probe |
• Lumbar Intervertebral Fusion Device with Bone Graft (FDA Code: MAX / 888.3080) |
• Manual Osteotome (FDA Code: GFI / 878.4800) |
• Medical 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. |
• Metal Laminoplasty Plate Spine Orthosis (FDA Code: NQW / 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. |
• Metal Mesh (FDA Code: EZX / 878.3300) Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery. |
• Metallic Bone Fixation Nail (FDA Code: NDH / 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. |
• Minimal Access |
• Minimal Access Systems, Transforaminal Lumbar Interbody Fusion |
• Multiple Component Fixation Appliance (FDA Code: KTT / 888.3030) |
• Nail/Blade/Plate Component Fixation Appliance (FDA Code: LXT / 888.3030) |
• Neurological Instruments, Pituitary Scoops |
• Neurology Self-Retaining Retractor (FDA Code: GZT / 882.4800) A self-retaining retractor for neurosurgery is a self-locking device used to hold the edges of a wound open during neurosurgery. |
• Neurosurgical Head Rest (FDA Code: HBM / 882.4440) A neurosurgical headrest is a device used to support the patient's head during a surgical procedure. |
• Non-Powered Goniometer (FDA Code: KQW / 888.1520) A nonpowered goniometer is a mechanical device intended for medical purposes to measure the range of motion of joints. |
• Non-Powered Surgical Instrument (FDA Code: HAO / 882.4535) A nonpowered neurosurgical instrument is a hand instrument or an accessory to a hand instrument used during neurosurgical procedures to cut, hold, or manipulate tissue. It includes specialized chisels, osteotomes, curettes, dissectors, elevators, forceps, gouges, hooks, surgical knives, rasps, scissors, separators, spatulas, spoons, blades, blade holders, blade breakers, probes, etc. |
• 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. |
• Nut Bolt Washer (FDA Code: HTN / 888.3030) |
• Occipital Fixation Systems |
• Old Plating Systems |
• Open |
• Ophthalmology, Surgical Instrument Trays |
• Orbital Procedures, Titanium Plating Systems |
• Orthopedic Cutting Instrument (FDA Code: HTZ / 878.4800) |
• Orthopedic Elevator (FDA Code: HTE / 878.4800) |
• Orthopedic Knife (FDA Code: HTS / 888.4540) |
• Orthopedic Manual Surgical Instrument (FDA Code: LXH / 888.4540) |
• Orthopedic Osteotome (FDA Code: HWM / 878.4800) |
• Percutaneous Biopsy Device (FDA Code: MJG / 878.4800) |
• Periodontal Probes |
• Pin Surgical Driver (FDA Code: GFC / 878.4820) Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade. |
• Piston Syringe (FDA Code: FMF / 880.5860) A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body. |
• Plating Systems |
• Posterior |
• Posterior Cervical Plating Systems |
• posterior cruciate ligament Instruments |
• Probes (FDA Code: HXB / 888.4540) |