Biomet Spine, LLC

  • 제조사 주소
    Biomet Spine, LLC, 399 Jefferson Rd, Parsippany NJ 07054-3707
  • 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
  • 1 Event

데이터베이스에서 발견된 의료기기 1건 데이터베이스에서 발견된 의료기기 1 건

  • 모델명 / 제조번호(시리얼번호)
    Part Numbers: 14-582020, 14-582022, 14-582025, 14-582030, 14-582035, 14-582040, 14-582120, 14-582122, 14-582125, 14-582127, 14-582130, 14-582135, 14-582140, 14-582220, 14-582222, 14-582225, 14-582230, 14-582235, 14-582240, 14-582245, 14-582250, 14-592320, 14-582325, 14-582330, 14-582335, 14-582340, 14-582345, 14-582350, 14-582530, 14-582535, 14-582540, 14-582545, 14-582550, 14-582565, 14-582570, 14-582575, 14-583020, 14-583025, 14-583030, 14-583035, 14-583040, 14-583120, 14-583125, 14-583130, 14-583135, 14-583140, 14-583220, 14-583225, 14-583230, 14-583235, 14-583240, 14-583245, 14-583250, 14-583320, 14-583325, 14-583330, 14-583335, 14-583340, 14-583345 and 14-583350. All lots.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Distribution US Nationwide (AL, CA, CO, FL, GA, LA, MA, MD, MI, MO, NY, OH, PA, TX, WA, WI) and The Netherlands.
  • 제품 설명
    Polaris 4.75 TI Spinal System, 4.0 x 20 MM, Closed MAS, Closed Head Multiaxial Screw, Non-Sterile, Rx Only, REF 14-583020, Biomet Spine and Bone Healing Technologies. Spinal fixation component.

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

데이터에 대해 더 자세히 알아보기 여기

  • 제조사 주소
    Biomet Spine, LLC, 310 Interlocken Pkwy Ste 120, Broomfield CO 80021-3464
  • 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