Device Recall STRYKER NAVIGATION SYSTEM SpineMap(TM) 3D Sales Demo SOFTWARE

  • Modèle / numéro de série
    All batches: JCK00F3015; JCX00F3015; K1F00F3015; K2Q00F3016; K2R00F3016; K3A00F3016; K3H00F3016; K3K00F3016; K7F00F3016; K8S00F3016; K9100F3016; KA900F3016; KBC00F3016; L1C00F3016; L6H00F3016; and L7900F3016.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- USA, Canada, Mexico, Australia, Argentina, Brazil, United Kingdom, Japan, Poland, S. Korea, Hong Kong, Taiwan, India, and New Zealand.
  • Description du dispositif
    Stryker Navigation System - SpineMap(TM) 3D - Sales Demo SOFTWARE, Part number 81-80045. 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

Fabricant

  • Adresse du fabricant
    Stryker Instruments Division of Stryker Corporation, 4100 East Milham Ave., Kalamazoo MI 49001
  • Société-mère du fabricant (2017)
  • Source
    USFDA