Comprehensive Shoulder Instruments Primary Shoulder Stem Inserter

  • 모델명 / 제조번호(시리얼번호)
    043190, 176120, 176130, 176140, 176150, 176870, 176900, 281960, 296760, 296770, 296780, 599260, 678800, 775960, 775980, 806060, 832070, 859290 and 884850.
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA (nationwide) including Puerto Rico; and countries of: Australia, Canada, Chile, Columbia, Costa Rica, Italy, Japan, Korea, Netherlands, New Zealand, Spain and Sweden.
  • 제품 설명
    Comprehensive Shoulder Instruments Primary Shoulder Stem Inserter, REF 407398, Biomet Orthopedics Warsaw, IN, Instrument used to introduce the stem into the canal. || The instrument is used to insert the shoulder implant into the shoulder.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Biomet, Inc., 56 E Bell Dr, Warsaw IN 46582
  • 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