Device Recall Solanas 2.1mm FIXED DEPTH DRILL, 10mm

  • 모델명 / 제조번호(시리얼번호)
    Lot No. 7117902
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution including CT, NC, AL, WV, IL, AR, and NY.
  • 제품 설명
    Solanas 2.1mm FIXED DEPTH DRILL, 10mm, Part No. 63928-10. Component of the SOLANAS III Posterior Stabilization System, 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