Product 5 consists of all products under product code HWC, and same usage: || Item no: || 47482701001 2.7MM CORT. SCREW 10MM, S || 47482701201 2.7MM CORT. SCREW 12MM, S || 47482701401 2.7MM CORT. SCREW 14MM, S || 47482701601 2.7MM CORT. SCREW 16MM, S || 47482701801 2.7MM CORT. SCREW 18MM, S || 47482702001 2.7MM CORT. SCREW 20MM, S || Product Usage: || 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.
“The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.
International Distribution including the country of Japan.
Description du dispositif
Zimmer Dental Calcitite 4060-2 Dense Nonresorbable Hydroxylapatite Bone Grafting Material, 4 ampules, 0.5g each, 40-60 mesh size, sterile. Zimmer Dental, Carlsbad, CA; Item # 0003. || Device is used for filling of periodontal defects following conventional curettage and debridement. The device is also indicated for the esthetic repair of bony defects of the alveolar ridge beneath new or existing fixed prosthetic restorations.
Worldwide Distribution, including USA, Australia, Austria, Belgium, Brazil, Canada, China, Colombia, Czech Republic, Denmark, England, Finland, France, Germany, Hong Kong, Hungary, India, Italy, Japan, Jordan, Latin America, Netherlands, Russia, Singapore, South Africa, South Korea, Spain, Switzerland, Taiwan, Thailand, Turkey and Venezuela.
Description du dispositif
Zimmer Coonrad/Morrey Total Elbow, Interchangeable Ulnar Assembly, plasma sprayed, extra small, right, long, sterile, Zimmer, Warsaw, IN; REF 32-8105-093-02. || The device is utilized for a total elbow arthroplasty surgical procedure.
International Distribution only -- Country of Germany.
Description du dispositif
Zimmer Most Hinged Tibia Baseplate Spacer, size 1, 6 mm, sterile, Zimmer, Warsaw, IN; REF 5020-06-001. || Component used to augment uni- and bi-compartmental defects and is manufactured from Ti-6A1-4V Alloy.
Worldwide Distribution -- US, Australia, and Germany.
Description du dispositif
Zimmer Nexgen Complete Knee Solution Fluted Stemmed Tibial Broach, Size 7, 8, nonsterile; REF 5997-61-07. || A reusable cutting instrument that is used in total knee arthroplasty surgery.
Worldwide Distribution - USA including states of CA, NY, MI, OH, WI, IA, MN, NJ, IL, MO, TX, LA, NC, SC, PA, AR, MS, FL, GA, AL, OK, KS, TN, CT, NM, UT, NV, ID and CO and Switzerland.
Description du dispositif
Zimmer Natural-Knee II System Modular Cemented Tibial Baseplate, Right, Size 0, TIB B/PL, for cemented use only, sterile, Zimmer, Warsaw, IN; Model Number: 6420-01-200. || The Natural-Knee II System Cemented Modular Tibial Baseplate is a nonporous component which may be used in total knee replacement surgery. The baseplate is intended for cemented use only.