Device Recall Invue Split Driver, Assembly with Handle

  • 모델명 / 제조번호(시리얼번호)
    Lot/Serial Numbers: 027104, 027105
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution including Texas, Ohio, and Missouri.
  • 제품 설명
    Invue Split Driver, Assembly with Handle, Model SI70006 Rev G. Used in conjunction with the Invue Anterior Cervical Plate System under 501(k) clearance number K121060. || The Invue Driver is an instrument consisting of a Radel handle, a shaft and hexalobe-like tip with a 4.0mm split, which allows the driver to collapse to fit into a screw and expand to retain the screw.
  • Manufacturer
  • 1 Event

제조사

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