Product 24 consists of all product under product code: HRS and same usage: || Item no: || 234703104 DISTAL MEDIAL FEMORAL CON || 234703206 DISTAL MEDIAL FEMORAL CON || 234703208 DISTAL MEDIAL FEMORAL CON || 234800504 DISTAL POSTERIOR/LATERAL || 234800506 DISTAL POSTERIOR/LATERAL || 234800508 DISTAL POSTERIOR/LATERAL || 234800510 DISTAL POSTERIOR/LATERAL || 234800604 DISTAL POSTERIOR/LATERAL || 234800606 DISTAL POSTERIOR/LATERAL || 234800608 DISTAL POSTERIOR/LATERAL || 234800610 DISTAL POSTERIOR/LATERAL || 234800614 DISTAL POSTERIOR/LATERAL || Product Usage: || 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.
“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.
There are no lot code(s) for the 01-8851-001-00 loaner part number due to when the device is physically manufactured, it is done so as part number 00-8851-001-00 and lot codes are assigned to this part number. The 01-8851-001-00 exists in order to differentiate that the device is being distributed as a loaner rather than a sale of the device
US Nationwide Distribution including states of: AL, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, and WI.
Description du dispositif
Zimmer¿ Air Dermatome II Handpiece Loaner, item number 01-8851-001-00. Device is packaged inside of a padded-foam corrugate box. A product label is applied to the lid of the box. The width plates, when sold individually, are placed in a labeled poly zipper bag, which is then placed into a corrugated shipper carton or padded envelope.
The TM Ardis Interbody System implant is a convex, straight TLIF or PLIF device for interbody fusion of the anterior column of the spine. TM Ardis is designed for fusing the adjacent bony surfaces and may be used to replace a disc at one or two contiguous levels in L2-S1. The superior and inferior surfaces of the device are textured to provide increased stability and convex to conform to the vertebral endplates. The device also has two slots on the posterior end to mate with the insertion instrument. The TM Ardis device is wholly comprised of Trabecular Metal Porous Tantalum. Surgical instrumentation for use with the proposed system will be fabricated from surgical grade stainless steel and other applicable materials.
Nationwide in USA; Internationally to: Australia, Brazil, Canada, China, El Salvador, Germany, Guatemala, India, Japan, Panama, Malaysia, Mexico, Netherlands, South Korea, Singapore, Taiwan & Trinidad.
Description du dispositif
Zimmer Trabecular Metal(TM) Reverse Shoulder System Instrumentation, Drill 2.5 mm Diameter, Item Number/EDI 47430904601, Sterile
Nationwide in USA; Internationally to: Australia, Brazil, Canada, China, El Salvador, Germany, Guatemala, India, Japan, Panama, Malaysia, Mexico, Netherlands, South Korea, Singapore, Taiwan & Trinidad.
Description du dispositif
Zimmer Periarticular Locking Plate System Locking Screw Tap Standard Quick-Connect, 2.7 mm Diameter, Item Number/EDI 00236015327, Nonsterile