Device Recall Spine Frontier Inspan Compressor

  • Modèle / numéro de série
    Lot Numbers: SFP02323, SFP02323R, and SFP02323RR
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution-USA (nationwide) including PR and the states of FL, MA, MO, OK, and TX, and the country of Mexico.
  • Description du dispositif
    Spine Frontier Inspan compressors || Part Number: 11-60004. || Inspan compressors provide pressure to drive spikes of Inspan implants into the spinous process bone, resulting in fixation of the implant.
  • 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