Device Recall Opteryx Variable Rescue Screw

  • 모델명 / 제조번호(시리얼번호)
    Lot #1601
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    US Nationwide Distribution in the states of  CA, UT, ID, TX, OH, and MN.
  • 제품 설명
    Opteryx Variable Rescue Screw, Part #CP2214, UDI: *+M711CP22140/$$801716012*. Packaged in heat-sealed plastic bag. || Product Usage: || 4.5mm x 14mm Anterior Cervical Plate System Variable Rescue Screw. The Opteryx¿ Cervical Plate System is intended as a temporary fixation device used for correction and stabilization of the cervical spine. Variable angle screws are included to allow the physician greater flexibility when placing the plates and securing it to the vertebrae.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Innovasis, Inc, 614 E 3900 S, Salt Lake City UT 84107-1902
  • 제조사 모회사 (2017)
  • Source
    USFDA