CapLOX II Pedicle Screw System

  • Modèle / numéro de série
    Model # 2201-5004, Lot # 06110093 Devices are also seialized as 101-110.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide Distribution (Distributed to one customer located in MN)
  • Description du dispositif
    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

Fabricant

  • Adresse du fabricant
    Captiva Spine, Inc, 967 Alternate A1A, Suite1, Jupiter FL 33477
  • Société-mère du fabricant (2017)
  • Source
    USFDA