Device Recall Omni Spine Anterior Cervical Plate System

  • Modèle / numéro de série
    Part No. CSF-40-12, Lot No. 132635
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    US Distribution to the states of : AR, CA, GA, LA, MD, NV, NY, OH and TX.
  • Description du dispositif
    Piranha Screw 4.0 x 12mm, used in Piranha Surgical Plate System || The Piranha Surgical Plate System is intended to provide stabilization of the cervical vertebrae for various indications as part of the Omni Spine Anterior Cervical Plate System. The Omni Spine Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-C7) as an adjustment to fusion in the treatment of degenerative disc disease (DDD), sponylolisthesis, spinal stenosis, tumors, trauma (i.e. fracture).
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Amendia, Inc dba Spinal Elements, 1755 W Oak Pkwy, Marietta GA 30062-2260
  • Société-mère du fabricant (2017)
  • Source
    USFDA