Anatomical Shoulder

  • 모델명 / 제조번호(시리얼번호)
    REF Numbers: 01.04227.400, 01.04227.405, 01.04227.480, and 01.04227.485 Lot 2352153, 2358721, 2366101, 2525804, 2494527, 2523912, 2385885, 2441471
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution.
  • 제품 설명
    Anatomical Shoulder" Fracture Humeral Head
  • Manufacturer
  • 1 Event

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 23 건

데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
    Lot Number(s):  13870129 &  13878179.
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Distributed to the states of IN, GA, WI, MO, PA, KS, TN, and NY.
  • 제품 설명
    Anatomical Shoulder Handle for Rasp || Item: 01.04233.000 || Used during total joint arthroplasty of the shoulder.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Item Number: 01.04227.005 Lot Numbers: 2792457 2794578 2812029 2817212 2844463 2794576 2794579 2815118 2817213 2847568 2794577 2794580 2815119 2832862
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution to AZ, CA, CO, GA, IL, KS, KY, MA, MD, MO, OH, PA, TN, and TX.
  • 제품 설명
    Dome Centric component (Reference 01.04227.005) from the Anatomical Shoulder (AS) System 2.0. || The Dome Centric connects the Humeral Stem to the Humeral Head and allows setting an inclination and retroversion positioning. || The Anatomical Shoulder System is intended for long-term implantation into the human shoulder joint in primary or revision, total or hemi shoulder arthroplasty. The system is intended to relieve pain and restore function in patients with adequate bone stock to support the prosthesis.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical instruments for use in humans - bone surgery
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
  • 이식된 장치?
    Yes
  • 제품 설명
    Non-active implants - bone surgery
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Sirus Drill Trauma Instrument and Flexible Shaft Hip & Anatomical Shoulder Instrument, Zimmer GmbH
  • Manufacturer
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