USA Nationwide Distribution including the states of: California and Texas.
Description du dispositif
Product is labeled in part: "***REF: 01-7036, LOT 999999, "1.5MM" SYSTEM PLATE L-SHAPE, 3 X 3 HOLE, 100 DEGREE, QTY 00001, CE 0086, 2010-04 *** NON-STERILE PRODUCT ***, LEFT, X-LONG, 0.6 MM TITANIUM, BIOMET MICROFIXATION, 1540 TRADEPORT DRIVE, JACKSONVILLE, FL 32218 USA, 01-736, LOT 999999, QTY 00001, L-SHAPE, 3 X 3 HOLE, 100 DEGREE, LEFT, X-LONG, 0.6 MM, CE 0086.***" || Product Usage - CTS Usage: || Bone-plate - internal fixation devices intended to aid in the alignment and stabilization of bone in the oral cranio-maxillofacial 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.
Belgium, Croatia, Denmark, Finland, France, Hong Kong, India, Jamaica, Netherlands, Nicaragua, Portugal, Romania and Russia.
Description du dispositif
ATLANTIS Element Express Kit; a sterile kit for cervical spine surgery which includes hex-head screwdriver, bone plate and 4 bone screws; catalog number 786-140.
Belgium, Croatia, Denmark, Finland, France, Hong Kong, India, Jamaica, Netherlands, Nicaragua, Portugal, Romania and Russia.
Description du dispositif
ATLANTIS Element Express Kit; a sterile kit for cervical spine surgery which includes hex-head screwdriver, bone plate and 4 bone screws; catalog number 786-123.
Belgium, Croatia, Denmark, Finland, France, Hong Kong, India, Jamaica, Netherlands, Nicaragua, Portugal, Romania and Russia.
Description du dispositif
ATLANTIS Element Express Kit; a sterile kit for cervical spine surgery which includes hex-head screwdriver, bone plate and 4 bone screws; catalog number 786-125.
Belgium, Croatia, Denmark, Finland, France, Hong Kong, India, Jamaica, Netherlands, Nicaragua, Portugal, Romania and Russia.
Description du dispositif
ATLANTIS Element Express Kit; a sterile kit for cervical spine surgery which includes hex-head screwdriver, bone plate and 4 bone screws; catalog number 786-127.
Belgium, Croatia, Denmark, Finland, France, Hong Kong, India, Jamaica, Netherlands, Nicaragua, Portugal, Romania and Russia.
Description du dispositif
ATLANTIS Element Express Kit; a sterile kit for cervical spine surgery which includes hex-head screwdriver, bone plate and 4 bone screws; catalog number 786-142.