Device Recall Zodiac Polyaxial Spinal Fixation System

  • 모델명 / 제조번호(시리얼번호)
    Part Number: 62665-50 Lot Number: 617945
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    AZ, CA, FL, TX
  • 제품 설명
    Zodiac Polyaxial Spinal Fixation System. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Alphatec Spine, Inc., 2051 Palomar Airport Rd Ste 100, Carlsbad CA 92011-1462
  • 제조사 모회사 (2017)
  • Source
    USFDA