Persona Cemented Tibial SZ PLT Size H Left

  • 모델명 / 제조번호(시리얼번호)
    Lot 63693589, UDI (01)00889024247574(10)63693589;  Lot 63649575, UDI (01)00889024247574(10)63649575;  Lot 63576035, UDI (01)00889024247574(10)63576035;  Lot 63531869, UDI (01)00889024247574(10)63531869
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution: US (nationwide) to states of: AK, AL, AR, AZ, CA, CO, FL, GA, IA, IL, IN, KS, KY, MA, MD, MI, MN, MO, MT, NC, NJ, NY, OH, OR, PA, SC, TX, UT, VA, WA, WI, and Puerto Rico; and to countries of: Australia, Canada, Hong Kong, India, Japan, Korea, Malaysia, Netherlands, and Singapore.
  • 제품 설명
    Persona Cemented Tibial SZ PLT Size H Left, Item Number 42539908301 || For use during orthopaedic surgery for implantation of a prosthesis.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Zimmer Biomet, Inc., 1800 W Center St, Warsaw IN 46580-2304
  • 제조사 모회사 (2017)
  • 제조사 의견
    “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.
  • Source
    USFDA