VerSys Femoral Head Provisional

  • 모델명 / 제조번호(시리얼번호)
    All lots distributed from lot 69998600 (2/20/1996) to present
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide) and internationally to Canada, Mexico, South America, Europe, Puerto Rico, China, and Korea.
  • 제품 설명
    00789502601 VerSys Femoral Head Provisional 26mm -3.5 || 00789502602 VerSys Femoral Head Provisional 26mm +0 || 00789502603 VerSys Femoral Head Provisional 26mm +3.5 || 00789502604 VerSys Femoral Head Provisional 26mm +7 || 00789502605 VerSys Femoral Head Provisional 26mm +10.5 || 12/14 Neck Taper || The provisional heads replicate final femoral implant geometry y and are used to trial range of motion, joint stability, and determine appropriate femoral head size and offset during total hip arthroplasty.
  • Manufacturer
  • 2 Events

제조사

  • 제조사 주소
    Zimmer, Inc., 345 E Main St, Warsaw IN 46580-2746
  • 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