Zimmer Trabecular Metal Reverse Shoulder System

제조사

  • 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
    NZMMDSA

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  • 모델명 / 제조번호(시리얼번호)
    All lots.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide distribution --- USA and countries of Australia and China
  • 제품 설명
    Zimmer Trabecular Metal Reverse Shoulder System Base Plate; Catalog/Ref No. 00-4349-038-00.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
  • 이식된 장치?
    Yes
  • 제품 설명
    Implant
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: 00-4309-029-01 (Lot serial: 60989817); Model Catalog: 00-4309-029-01 (Lot serial: 61024161); Model Catalog: 00-4309-029-01 (Lot serial: 61011689); Model Catalog: 00-4309-028-00 (Lot serial: 6109783); Model Catalog: 00-4309-028-01 (Lot serial: 61051017); Model Catalog: 00-4309-028-01 (Lot serial: 60936815); Model Catalog: 00-4309-029-00 (Lot serial: 61004027)
  • 제품 설명
    ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM INSTRUMENTATION LINER IMPACTOR 36MM 65 DEGREE NECK ANGLE
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: 00-4349-038-11 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: 00-4349-036-11 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: 00-4349-040-11 (Lot serial: >100 NUMBERS CONTACT MFR)
  • 제품 설명
    TRABECULAR REVERSE SHOULDER BASE PLATES
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Surgical Technique, Catalog Number: 97-4309-003-00, Rev. 4.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - USA, Nationwide, Switzerland and Eschbach, Germany, Switzerland, Australia, China, India, Japan, Korea, Malaysia, Singapore, Taiwan, Brazil, Venezuela, El Salvador, Colombia, Canada, and Thailand.
  • 제품 설명
    Zimmer¿ Trabecular Metal Reverse Shoulder System Surgical Technique. Catalog Number 97-4309-003-00, Rev. 4. || The Zimmer Trabecular Metal Reverse Shoulder System is a treatment option for patients with severe rotator cuff (RC) deficiency. The stem was designed so that its bearing surfaces, as compared to a traditional humeral stem, is such that the humeral component contains a concave ultra-high molecular weight polyethylene (UHMWPE) liner that articulates with a hemispheric metallic glenoid component. System is used for: -the treatment of severe pain or significant disability in degenerative, rheumatoid, or traumatic disease of the glenohumeral joint; - ununited humeral head fractures of long duration; - irreducible 3-and 4-part proximal humeral fractures; - avascular necrosis of the humeral head, or other difficult clinical management problems where arthrodesis or resectional arthroplasty is not acceptable.
  • Manufacturer
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