Device Recall STRYKER NAVIGATION SYSTEM SpineMap 3D Planning

  • Modelo / Serial
    Verision 1.0; all batches: K8T00F3004 and KB500F3004.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- USA, Canada, Mexico, Australia, Argentina, Brazil, United Kingdom, Japan, Poland, S. Korea, Hong Kong, Taiwan, India, and New Zealand.
  • Descripción del producto
    Stryker Navigation System - SpineMap 3D - Planning, Part number 6002-651-000. It provides precise stereostatic determination of surgical targets using stereostatic methodology. The three principle features include computer calculation of stereostatic coordinates from the diagnostic images, measurement of the stereostatic coordinates within the surgical field, high-resolution computer display or diagnostic images with stereostatic coordinates indicated. The system is comprised of software and hardware components.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Stryker Instruments Division of Stryker Corporation, 4100 East Milham Ave., Kalamazoo MI 49001
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA