Device Recall TRYPTIK(R) 2 CPLATE SELFTAPPING POLYAXIAL SCREW 4.0 MM, 04 L14, REF TRYPS40 14S

  • 모델명 / 제조번호(시리얼번호)
    batch: 3-5936
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    US Distribution to the state of : CA
  • 제품 설명
    TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.5 MM, LENGTH 12 MM, REF TRY-PS-45 12-S, Qty 2 || TRYPTIK(R) 2C-Plate Anterior Cervical Plate System is intended to be used for temporary stabilization of the cervical spine (C2-C7) during the development of solid spinal fusion in patients with instability caused by the following degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumor, spondylolisthesis, spinal stenosis, deformity (i.e., scoliosis, kyphosis, lordosis), pseudarthrosis, and failed previous fusions.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    SPINEART SA, route de Pre bois 20, Case Postale 1813, Geneva 15 Switzerland
  • 제조사 모회사 (2017)
  • Source
    USFDA