Device Recall PERPOS 2in1 Drills

  • Modèle / numéro de série
    Lot#110806A
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) including states of: CA, FL, MO, NY, OH, PA, TN, WA, and WI; and country of: Europe.
  • Description du dispositif
    PERPOS 2-in-1 Drills, Catalog #6070 || Component Part #6070 for PERPOS 2-in-1 Drill-a canulated, 2 step drill to be used over a K-wire to remove bone prior to the 4.5mm BONE-LOK PLS Implant (LSW-45-3040) being placed. The PERPOS 2-in-1 Drill (6070) is sold as either a component of the Single Use PERPOS PLS System (9045-01, 9045-02) or as a stand-alone tool.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Interventional Spine Inc, 13700 Alton Pkwy Ste 160, Irvine CA 92618-1618
  • Société-mère du fabricant (2017)
  • Source
    USFDA