Gender Solutions

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
    AFMPS

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데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
    Lot Number: 60998487.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution -- US including states of FL, MN, MS, NY, OH, TN, TX and WI and Switzerland.
  • 제품 설명
    Zimmer Gender Solutions Natural Knee Flex System, Gender Solutions Male, Femoral Component, nonporous, size 4, left, sterile, Zimmer, Warsaw, IN; Product Number: 00-5410-017-01. || Knee implant used to replace the distal surface of the human femur in total knee arthroplasty surgery. For use in Non-inflammatory Degenerative Joint Disease or Inflammatory Joint Disease, deformity, moderate contracture or failed previous surgery. Product is indicated for uncemented or cemented use.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Part Number Range:00-5926-011/015-01/02
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Dominican Republic, Ecuador, El Salvador, Germany, Guatemala, Honduras, Hong Kong, India, Israel, Jamaica, Japan, Korea, Malaysia, Mexico, New Zealand, Nicaragua, Panama, Peru, Singapore, Taiwan, Thailand, and Venezula.
  • 제품 설명
    Gender Solutions" Patello-Femoral Component
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Item Numbers 00541800000 00541800001 00541800002
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution-USA (nationwide) including DC and the states of AK, AL, AR, AZ, CA, CO, CT, FL, IL, IN, KS, LA, ME, MI, MO, MS, NC, ND, NE, NJ, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA, and WI, and the countries of Canada, Australia, India, Austria, Japan, Czech Republic, Seoul Korea, France, Venezuela, Germany, Luxembourg, Spain, and Switzerland.
  • 제품 설명
    Gender Solutions" Natural-Knee¿ Flex System: || N-K FLEX MBACK SZ 0 PAT || N-K FLEX MBACK SZ 1 PAT || N-K FLEX MBACK SZ 2 PAT
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    see list
  • 제품 설명
    MD: Tibial insert
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    see FSN | see FSN
  • 제품 설명
    MD: Knee prosthesis, internal
  • Manufacturer
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