Device Recall Polyaxial Pedicle Screw

  • 모델명 / 제조번호(시리얼번호)
    Catalog/Part No.: E2S8530, E2S8535, E2S8540, E2S8545, E2S8550, E2S8555, E2S8560 with Lot Number: 1101 and Catalog/Part No.: E28540, E28545 with Lot Number: 1201. Each of these parts is engraved with part number and lot number.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    United States
  • 제품 설명
    Excella II Polyaxial Pedicle Screw used as a pedicle screw system in skeletally mature patients, is intended to provide immobilization and stabilization of spinal segments, as an adjunct to fusion, in treatment of the following acute and chronic deformities of the thoracic, lumbar, and sacral spine:
  • Manufacturer
  • 1 Event

제조사

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