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Zimmer, Inc.


Web: http://www.zimmer.com
Address: P.O. Box 708 ,1800 West Center Street, Warsaw, Indiana 46581-0708, USA
Phone: +1-(574)-372-4790, 800-613-6131 | Fax: +1-(574)-372-4988 | Map/Directions >>
 
 

Profile: Zimmer, Inc. manufactures orthopedic products and instruments. We specialize in joint replacement solutions for knee pain & hip pain. We deliver comprehensive spine care solutions for acute and chronic back pain. Our dynesys spinal system is an investigational device that represents a new concept intended to relieve back and leg pain. The dynesys system uses flexible materials to stabilize the affected lumbar region while preserving the natural anatomy of the spine. Our Sirus® Nail System is designed for reamed and unreamed intramedullary femoral and tibial surgical techniques. Our PEEK-OPTIMA® implant can be used in a variety of surgical approaches including TLIFs & PLIFs and is ideal for open, mini-open or MIS techniques. Our Puros® Symmetry®PLIF Allograft System is the only posterior lumbar interbody fusion system that offers an allograft spacer that originates from a single doner.

The company was founded in 1927, has revenues of > USD 1 Billion, has ~7600 employees and is ISO 9001, CE certified. NYSE:ZMH (SEC Filings)

FDA Registration Number: 1822565

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• Self Retaining Brain Retractor
• Self-Opening Iris Scissors
• Semi-Constrained Elbow Prosthesis (FDA Code: JDB / 888.3160)
An elbow joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace an elbow joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that consist of a humeral resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a radial resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (888.3027).
• Semi-Constrained Femorotibial Knee Prosthesis (FDA Code: HRY / 888.3530)
A knee joint femorotibial metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that consist of a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (888.3027).
• Semi-Constrained Hip Prosthesis (FDA Code: JDL / 888.3320)
A hip joint metal/metal semi-constrained, with a cemented acetabular component, prosthesis is a two-part device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that consist of a femoral and an acetabular component, both made of alloys, such as cobalt-chromium-molybdenum. This generic type of device is limited to those prostheses intended for use with bone cement (888.3027).
• Semi-Constrained Patellofemoral Knee Prosthesis (FDA Code: KRR / 888.3540)
A knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis is a two-part device intended to be implanted to replace part of a knee joint in the treatment of primary patellofemoral arthritis or chondromalacia. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes a component made of alloys, such as cobalt-chromium-molybdenum or austenitic steel, for resurfacing the intercondylar groove (femoral sulcus) on the anterior aspect of the distal femur, and a patellar component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those devices intended for use with bone cement (888.3027). The patellar component is designed to be implanted only with its femoral component.
• Semi-Constrained Patellofemorotibial Knee Prosthesis (FDA Code: JWH / 888.3560)
A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (888.3027).
• Shiatsu Back Support
• Shin Splints
• Shoes & Boots
• Shoulder Immobilizer with Abduction Pillow
• Shoulder Immobilizers
• Shoulder joint Prosthesis
• Shoulder Prosthesis
• Shoulder Restraint
• Silicone Elastic Ankle Support
• Silicone Evacuator With Hubless Flat Drain
• Silicone Penrose Drainage Tube
• Silicone T-Y Drainage Tube
• Silicone Tubing
• Silicone Tubing, Medical Grade
• Silicone Y-Drainage Tube
• Single Prong Skin Hooks
• Skin Graft Cutter
• Skin Graft Surgical Expander (FDA Code: FZW / 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.
• Skin Hook Forceps
• Skin Hooklet
• Skin hooks
• Skin Pressure Protector (FDA Code: FMP / 880.6450)
A skin pressure protector is a device intended for medical purposes that is used to reduce pressure on the skin over a bony prominence to reduce the likelihood of the patient's developing decubitus ulcers (bedsores).
• Skull Tongs
• 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.
• Slippers
• 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.
• Small Neutral & Loaded Drill Guide
• Smooth Fixation Pin (FDA Code: HTY / 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.
• Socket Positioner (FDA Code: KIL / 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.
• Socket Pusher (FDA Code: HXO / 888.4540)
• Soft Rib Fracture Orthosis (FDA Code: IPX / 890.3490)
A truncal orthosis is a device intended for medical purposes to support or to immobilize fractures, strains, or sprains of the neck or trunk of the body. Examples of truncal orthoses are the following: Abdominal, cervical, cervical-thoracic, lumbar, lumbo-sacral, rib fracture, sacroiliac, and thoracic orthoses and clavicle splints.
• Soft Sacroiliac Orthosis (FDA Code: IPW / 890.3490)
• Soft Tissue Non-Biodegradable Fixation Fastener (FDA Code: MBI / 888.3040)
• Spare Hook for K Nail Extractor
• Sphenoid Bone Punches
• Spinal Cervical Intervertebral Body Fixation Orthosis
• Spinal Disc Shaving Equipment
• 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 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 Accessories (FDA Code: LYQ / 888.1520)
• 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 Vertebral Body Replacement Device (FDA Code: MQP / 888.3060)

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