RTI Surgical Streamline OCT OccipitoCervicoThoracic Spinal Rod

  • Modèle / numéro de série
    Part Number: 23-CC-ROD-240; Lot Number: 234829, UDI Number: (01)0084646802 7179( 10}234829; Lot Number: 246678, UDI Number: {01}00846468027179{10}246678
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    US Nationwide Distribution in the states of: AL, CA, CO, FL, IN, IL, MI, MO, MS, NC, NY, OK, TN, TX, and VA,.
  • Description du dispositif
    RTI Surgical Streamline OCT Occipito-Cervico-Thoracic Spinal Rod, CoCr, 3.2mm (D) x 240mm (L) || Product Usage: || When intended to promote fusion of the cervical spine and occipitocervico-thoracic junction (occiput-T3), the Streamline OCT Occipito-Cervico-Thoracic System is intended for: degenerative disc disease (as defined by neck or back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture/ dislocation, atlanto/axial fracture with instability, occipito-cervical dislocation, deformities or curvature, tumors, pseudoarthrosis, and revision of previous cervical and upper thoracic spine surgery. The occipital bone screws are limited to occipital fixation only. The use of the pedicle screws (standard and high angle) is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. The pedicle screws are not intended for use in the cervical spine. The hooks, connectors, and rods are also intended to provide stabilization to promote fusion following reduction of fracture/ dislocation or trauma in the cervical/ upper thoracic (C1-T3) spine.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.), 375 River Park Cir, Marquette MI 49855-1781
  • Société-mère du fabricant (2017)
  • Source
    USFDA