Azure

  • 모델명 / 제조번호(시리얼번호)
    86-01xx, 86-02xx, 86-03xx, 86-04xx, 86-05xx  All lot numbers manufactured to date
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution: USA (nationwide) and the country of Germany.
  • 제품 설명
    Azure Anterior Cervical Plate System, 2-Level Plate, 36 mm, Implant Grade Titanium and Nitinol, Orthofix Inc., RX Only || The Azure Anterior Cervical Plate System is a temporary implant, intended for anterior fixation to the cervical spine from C2 to C7 and is indicated for: A. Degenerative disc disease, B. Spondylolisthesis, C. Trauma, D. Spinal Stenosis, E. Deformities, F. Tumor, G. Pseudoarthrosis, and H. Revision of previous surgery. The Azure Anterior Cervical Plate System is comprised of a variety of non-sterile, single use, titanium alloy and nitinol components. The system is attached to the anterior aspect of the vertebral body by means of screw to to the cervical spine.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Orthofix, Inc, 3451 Plano Pkwy, Lewisville TX 75056-9453
  • 제조사 모회사 (2017)
  • Source
    USFDA

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 2 건

데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
  • 이식된 장치?
    Yes
  • 제품 설명
    Non-active implants - bone surgery
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
  • Manufacturer