Slotted Femoral Head Provisional

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

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 2 건

데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
    All lots including lot 78939000 (1/7/2002) 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
    00780302201 MIS 12/14 Slotted Femoral Head Provisional -2X22 || 00780302202 MIS 12/14 Slotted Femoral Head Provisional +0X22 || 00780302203 MIS 12/14 Slotted Femoral Head Provisional +3.5X22 || The provisional heads replicate final femoral implant geometry and are used to trial range of motion, joint stability, and determine appropriate femoral head size and offset during total hip arthroplasty.
  • Manufacturer
  • 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 countries of: Asia, Barbados, Canada, Europe, Mexico, Puerto Rico, San Juan, and South America.
  • 제품 설명
    00780304001 MIS 12/14 Slotted Femoral Head Provisional -3.5X36 || 00780304002 MIS 12/14 Slotted Femoral Head Provisional +0X36 || 00780304003 MIS 12/14 Slotted Femoral Head Provisional +3.5X36 || 00780304004 MIS 12/14 Slotted Femoral Head Provisional +7X36 || 00780304005 MIS 12/14 Slotted Femoral Head Provisional +10.5X36 || The provisional heads replicate final femoral implant geometry and are used to trial range of motion, joint stability, and determine appropriate femoral head size and offset during total hip arthroplasty.
  • Manufacturer