Device Recall SLIFT Extension Shims

  • 모델명 / 제조번호(시리얼번호)
    Part Number/Lot Number: 11-50109 43092R; 11-50109 46415; 11-50109 CT12H013; 11 -50109-1 46415-1; 11-50110 43089; 11-50110 43089R; 11-50110 46416; 11-50110-1 46416-1
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution including FL, TX, OK, MO, IL, OH, VA, OR, CO, KS, CT
  • 제품 설명
    S-LIFT Extension Shims || Extension shims are manufactured from grade 5 titanium and are curved, rectangular slabs which have four protrusions used for ratcheting. They come in straight and pointed varieties, either with or without a tab containing an additional bend. Extension shims are designed to slide down retractor blades, and are optional retractor components utilized during lumbar interbody fusion procedures. They are intended to manipulate tissue and prevent tissue from interfering inside the surgical field.
  • Manufacturer
  • 1 Event

제조사

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