Device Recall Transforminal Lumbar Interbody Fusion (TLIF) PEEK Inserter

  • 모델명 / 제조번호(시리얼번호)
    Model GP200. The four inserters were labeled with GP 200, Lot #1086.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution including Florida and Texas.
  • 제품 설명
    Transforminal Lumbar Interbody Fusion (TLIF) PEEK Inserter used in the Genesys Spine Apache" Interbody Fusion System. || The TLIF PEEK inserter is used to introduce the TLIF PEEK implant into the patients spine by threading the implant onto the tip of the inserter shaft. Once the implant is seated within the vertebrae the inserter is removed by unthreading the inserter from the implant.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Genesys Orthopedic Systems, LLC, 1250 S Capital Of Texas Hwy, Bldg #3, Suite 600, Austin TX 78746-6446
  • Source
    USFDA