Depuy Spine, Inc.

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Web: http://www.depuyacromed.com
E-Mail:
Address: 325 Paramount Drive, Raynham, Massachusetts 02767, USA
Phone: +1-(508)-880-8100 | Fax: +1-(508)-828-3192 | Map/Directions >>
 
 

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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• AC-Powered Surgical Instrument Motor (FDA Code: GEY / 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.
• Allografts
• Anterior
• Anterior Cervical Plate
• Anterior Cruciate Ligament Surgical Reconstruction System
• Anterior Lumbar Plate System
• Anterior Odontoid Screw Fixation
• Anterior Old Plating Systems
• Arthroscopes (FDA Code: HRX / 888.1100)
An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.
• Awl (FDA Code: HWJ / 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.
• Bender (FDA Code: HXW / 888.4540)
• Bending/Contouring Instrument (FDA Code: HXP / 888.4540)
• Bio Absorbable Plating Systems
• Bioabsorbable synthetic spacers
• Bipolar Electrode Cables
• 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)
• Bone Fixation Screw (FDA Code: HWC / 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.
• Bone Graft Replacement
• Bone Growth Stimulators
• Bone Taps (FDA Code: HWX / 888.4540)
• Bone Trephine (FDA Code: HWK / 888.4540)
• Broach (FDA Code: HTQ / 888.4540)
• Cables
• Cables, Extension Cables Disposable and Reusable
• Calcium Compound Bone Void Filler (FDA Code: MQV / 888.3045)
A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.
• Calipers (FDA Code: KTZ / 888.4150)
A caliper for clinical use is a compass-like device intended for use in measuring the thickness or diameter of a part of the body or the distance between two body surfaces, such as for measuring an excised skeletal specimen to determine the proper replacement size of a prosthesis.
• Cannulated Drill Bit
• Cervical Immobilizer
• Cervical Intervertebral Fusion Device With Bone Graft (FDA Code: ODP / 888.3080)
• Cervical Spine Retractor System, Hand Held Instruments
• Compression Instrument (FDA Code: HWN / 888.4540)
• Corpectomy systems
• Curettes (FDA Code: HTF / 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.
• 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.
• Diagnostic EP Systems
• Diagnostic EP Systems, Cables
• Disposable Aspiration and Injection Needle (FDA Code: GAA / 878.4800)
• Drill Bit (FDA Code: HTW / 888.4540)
• Drill Bits & Bone Taps
• ECG Cables
• Electrosurgical Electrode Cables
• Endoscope Cleaning Brushes & Accessories (FDA Code: MNL / 876.1500)
An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.
• Enteral Irrigation Kit w/Piston Syringe
• External Bone Growth Stimulators
• Facet Screw Spinal Device System (FDA Code: MRW)
• Femoral Neck Punch (FDA Code: HWP / 888.4540)
• Femoral Ring Allografts
• Fixation Cerclage (FDA Code: JDQ / 888.3010)
A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as cobalt-chromium-molybdenum, and that consists of a metallic ribbon or flat sheet or a wire. The device is wrapped around the shaft of a long bone, anchored to the bone with wire or screws, and used in the fixation of fractures.
• Flexible Depth Gauge (FDA Code: HTJ / 888.4300)

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