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

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• 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.

• Prosthesis Driver (FDA Code: HWR / 888.4540)

• Reamer (FDA Code: HTO / 888.4540)

• Refrigerated Centrifuges (FDA Code: JQC / 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.

• Removable synthetic spacers

• Rib Rongeurs (FDA Code: HTX / 888.4540)

• Screwdriver (FDA Code: HXX / 888.4540)

• Shoulder Abduction Splint

• Single Component Fixation Appliance (FDA Code: KTW / 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.

• Skull Clamps and Pins

• Skull Traction Tongs (FDA Code: HAX / 882.5960) Skull tongs for traction is an instrument used to immobilize a patient with a cervical spine injury (e.g., fracture or dislocation). The device is caliper shaped with tips that penetrate the skin. It is anchored to the skull and has a heavy weight attached to it that maintains, by traction, the patient's position.

• Small Depth Gauge (FDA Code: HTJ / 888.4300) A depth gauge for clinical use is a measuring device intended for various medical purposes, such as to determine the proper length of screws for fastening the ends of a fractured bone.

• Spinal Cervical Intervertebral Body Fixation Orthosis

• Spinal Fixation Device Implant (FDA Code: JDN / 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 Implant Removal System

• 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)

• 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 Pedicle Screw Fixation Appliance System (FDA Code: MCV)

• Spinal Vertebral Body Replacement Device (FDA Code: MQP / 888.3060)

• Spondylolisthesis Spinal Fixation Orthosis (FDA Code: MNH / 888.3070)

• Surgical Hammer (FDA Code: FZY / 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.

• Surgical Instrument Tray (FDA Code: FSM / 878.4800)

• Surgical Needle Guide (FDA Code: GDF / 878.4800)

• Surgical Orthopedic Scissors (FDA Code: HRR / 888.4540)

• Surgical Pliers (FDA Code: HTC / 878.4800)

• Surgical Positioning Board

• Surgical Retainer (FDA Code: GCZ / 878.4800)

• Surgical Retractor (FDA Code: GAD / 878.4800)

• Surgical Retractor Systems (FDA Code: GAD / 878.4800)

• Surgical Titanium Mesh Implants

• Synthetic Spacers

• 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)

• 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) 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.

• Traction Accessories (FDA Code: ILZ / 890.5925) A traction accessory is a nonpowered accessory device intended for medical purposes to be used with powered traction equipment to aid in exerting therapeutic pulling forces on the patient's body. This generic type of device includes the pulley, strap, head halter, and pelvic belt.

• Traction Accessories, Leg Straps (FDA Code: ILZ / 890.5925)

• Tripolar Electrode Cables

• Upper Body Immobilizer

• Vertebroplasty (Does Not Contain Cement) Injector (FDA Code: OAR / 888.4200) A cement dispenser is a nonpowered syringe-like device intended for use in placing bone cement (888.3027) into surgical sites.

• Vertebroplasty Bone Cement (FDA Code: NDN / 888.3027) Polymethylmethacrylate (PMMA) bone cement is a device intended to be implanted that is made from methylmethacrylate, polymethylmethacrylate, esters of methacrylic acid, or copolymers containing polymethylmethacrylate and polystyrene. The device is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.

• Wire Cutters (FDA Code: HXZ / 888.4540)

• Wrench (FDA Code: HXC / 888.4540)