Device Recall Serrated Soft Tissue Shields

  • 모델명 / 제조번호(시리얼번호)
    Part numbers X079-0096 and X079-0097 with Lot #12320
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    US Distribution including the states of FL and MO.
  • 제품 설명
    Serrated Soft Tissue Shields. Orthopedic surgical instruments, part of the Silex Sacroiliac Fusion System. The soft tissue shields are surgical instrument guides in the Silex Sacroiliac Joint Fusion System for spinal surgery.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    X Spine Systems Inc, 452 Alexandersville Rd, Miamisburg OH 45342-3658
  • 제조사 모회사 (2017)
  • Source
    USFDA