Genesys Orthopedics Systems, LLC

데이터베이스에서 발견된 의료기기 1건 데이터베이스에서 발견된 의료기기 1 건

  • 모델명 / 제조번호(시리얼번호)
    Lot numbers: 10923, 109231, 11476, 11993, WT20150630A
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    US Distribution to the states of : FL, TX, NY, IL, GA, AL, MA, MO
  • 제품 설명
    Genesys spine, Binary Screwdriver, GCP221, component of the Binary Anterior Cervical Plating System || The Genesys Spine Binary Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to C7). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spondylolisthesis, trauma (i.e. fractures or dislocations), tumors, deformity (defined as kyphosis, lordosis, or scoliosis),pseudoarthrosis, failed previous fusion, and/or spinal stenosis.

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 1 건

데이터에 대해 더 자세히 알아보기 여기

  • 제조사 주소
    Genesys Orthopedics Systems, LLC, 1250 S Capital Of Texas Hwy, Bldg #3, Suite 600, Austin TX 78746-6446
  • 제조사 모회사 (2017)
  • Source
    USFDA