Device Recall Synaptive Medical BrightMatter Navigator System

  • Modelo / Serial
    00260001  00260002 00260006 00260007 00260005 00260003 00260004 00260012
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US: FL, WI, IL, LA, WA.
  • Descripción del producto
    Synaptive Medical BrightMatter Navigator System (Guide System). Part number SYN-0026. The Guide system is comprised of a cart labelled SYN-0024 and a cart labelled SYN-0025, Operator Cart. A planning and intraoperative guidance system to enable open and percutaneous computer assisted surgery. The system is indicated for medical conditions requiring neurosurgical cranial procedures. It can be used for intra-operative guidance where a reference to a rigid anatomical structure can be identified.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Synaptive Medical, Inc., 101 College Street, Suite 200, MaRS Centre, South Tower, Toronto Canada
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA