Device Recall InSpan Inserter

  • Modèle / numéro de série
    Right Assembly: 43097, 44614, 43097R; Left Assembly: 43098, 44615, 43098R
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA Nationwide: in the states of: FL, CO, VA, KS, TX, OH, TN, OK, CA, IL, MO, MN, Wash DC, including PR and the countries of Dominican Republic, Medico, Panama
  • Description du dispositif
    InSpan Inserter, Right Assembly; InSpan Inserter, Left Assembly || Product Usage: || Inserters are stainless steel instruments that have an inner shaft. The left and right inserters are used in combination with each other to place the implants into the body. Inserters are used to install the InSpan Spinous Plate System for the purpose of achieving supplemental fixation.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    SpineFrontier, Inc., 500 Cummings Ctr Ste 3500, Beverly MA 01915-6516
  • Société-mère du fabricant (2017)
  • Source
    USFDA