Device Recall SpineWave

  • Modèle / numéro de série
    Lot Codes: 092514Z, 120814A, 011415H and 022415F
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Nationwide Distribution in the state of CA, FL, GA, LA, MA, MD, MI, MO, NC, NH, OH, OR, PA, TX, and VA.
  • Description du dispositif
    Spine Wave Access Kit, Catalog Number 10-1530 || Package contents: RLSP494-Rhythmlink Monopolar Stimulating Probe and 10-1525 Disposable Dilator Set. || Product Usage: || The Spine Wave Access Kit is comprised of a sterile monopolar stimulating probe (individually packaged by Rhythmlink International) and a set of three sterile disposable dilators (individually packaged by Spine Wave). The Rhythmlink International Monopolar Stimulating Instrument is indicated for stimulation of cranial and peripheral motor nerves for location and identification during surgery, including spinal nerve roots.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Spine Wave, Inc., 3 Enterprise Dr Ste 302, Shelton CT 06484-4694
  • Société-mère du fabricant (2017)
  • Source
    USFDA