Device Recall Solanas Posterior Stabilization System

  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: 608227B, 609867B, 609870B, 609882B, 609897B, 609971B
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution-including the states of CA, CT, FL, GA, NC, NE, NJ, TX, and UT.
  • 제품 설명
    Solanas Posterior Stabilization System Part Number: 63920. || Solanas Posterior Stabilization System facilitates the surgical correction of spinal deformities by providing temporary internal fixation and stabilization during bone graft healing and/or fusion mass development. The Solanas Posterior Stabilization System is a spinal fixation system intended to improve stability of the cervical and thoracolumbar area of the spine (C1-T3).
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Alphatec Spine, Inc., 5818 El Camino Real, Carlsbad CA 92008-8816
  • 제조사 모회사 (2017)
  • Source
    USFDA