Spine Wave

  • Modèle / numéro de série
    Lot #572H09 Use by 2012-06
  • Classification du dispositif
  • Distribution
    Nationwide Distribution including Delaware, Massachusetts, Maryland, and New York
  • Description du dispositif
    StaXx¿ XD Expandable Cartridge Convex Expandable Implant 25mm (L) x 9mm (W) x 7mm (H) || Catalog number: 11-1525 || The StaXx¿ XD System is a vertebral body replacement device intended for use in the thoracolumbar spine (TI-L5) to replace and restore height of a collapsed, damaged, or unstable vertebral body or portion thereof, due to tumor or trauma (i.e., fracture). The system is to be placed bilaterally and used with autograft or allograft and supplemental spinal fixation. The supplemental fixation system that is intended to be used with the StaXx¿ XD System is the CapSure¿ PS Spine System.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Spine Wave Inc, Two Enterprise Drive, Suite 302, Shelton CT 06484
  • Société-mère du fabricant (2017)
  • Source
    USFDA