Devices

The SYMBIONIC LEG

  • Modèle / numéro de série
    Symbionic Item Numbers:   SBL12002 SBL12006 SBL12012 SBL12016 SBL12102 SBL12112 SBL12202 SBL12212 SBL12902 SBL12903 SBL12912 SBL12913  Serial #s affected: 321245, 322095, 322276, 322894; 710119-710322
  • Classification du dispositif
    Physical Medicine Devices
  • Distribution
    US Nationwide distribution.
  • Description du dispositif
    The SYMBIONIC LEG is an integrated prosthetic leg for transfemoral and knee disarticulation amputees. || Product Usage: SYMBIONIC LEG is intended for continuous use by amputees of low to moderate impact levels that weigh less than 125 kg for foot categories 25 30 and less than 100kg for foot categories 22, 23 and 24. The system is not intended for athletic use.
  • Manufacturer
    Ossur Americas, Inc.
  • 1 Event

Fabricant

Ossur Americas, Inc.
  • Adresse du fabricant
    Ossur Americas, Inc., 19762 Pauling, Foothill Ranch CA 92610-2611
  • Société-mère du fabricant (2017)
    Össur hf
  • Source
    USFDA