Device Recall Spine Frontier Inspan Compressor

  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: SFP02323, SFP02323R, and SFP02323RR
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution-USA (nationwide) including PR and the states of FL, MA, MO, OK, and TX, and the country of Mexico.
  • 제품 설명
    Spine Frontier Inspan compressors || Part Number: 11-60004. || Inspan compressors provide pressure to drive spikes of Inspan implants into the spinous process bone, resulting in fixation of the implant.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    SpineFrontier, Inc., 500 Cummings Ctr Ste 3500, Beverly MA 01915-6516
  • 제조사 모회사 (2017)
  • Source
    USFDA