PERSONA" The Personalized Knee System

  • 모델명 / 제조번호(시리얼번호)
    Part Number 42-5299-001-00 Lots: 56572679; 56573170; 56572918; 56573378; 56572975; 56573379; 56572978; 56574223; 56572981; 56574291; 56572982; 56574292; 56573071; 56574316; 56573115; 56574317; 56573116; 56574318; 56573154.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - USA (nationwide) including the states of NY, OR, NC, OH, TX, FL, CO, IN, TN, PA, CA, KS, MO, WI, VA, MN, NJ, UT, MA, GA, MI, OK, AZ, MS, IL and AL., and the countries of Korea, Singapore, Canada and Japan
  • 제품 설명
    The Persona Tibial Articular Surface Inserter is a sterilizable instrument intended for || use in multiple total knee arthroplasty procedures. Per the Persona Surgical || technique, the Persona Tibial Articular Inserter is used to seat the articular surface || implant onto the tibial baseplate.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Zimmer, Inc., 1800 W Center St, Warsaw IN 46580-2304
  • 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