CapLOX II Pedicle Screw System

  • 모델명 / 제조번호(시리얼번호)
    Model # 2201-5004, Lot # 06110093 Devices are also seialized as 101-110.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution (Distributed to one customer located in MN)
  • 제품 설명
    CapLOX II Final Torque Driver, Indicator is a Pedicle screw spinal system. || The CapLOX II Spinal System is a posterior, non-cervical pedicle fixation system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine including degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, pseudoarthrosis and failed previous fusion.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Captiva Spine, Inc, 967 Alternate A1A, Suite1, Jupiter FL 33477
  • 제조사 모회사 (2017)
  • Source
    USFDA