Device Recall Opteryx Variable Rescue Screw

  • Modèle / numéro de série
    Lot #1601
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    US Nationwide Distribution in the states of  CA, UT, ID, TX, OH, and MN.
  • Description du dispositif
    Opteryx Variable Rescue Screw, Part #CP2214, UDI: *+M711CP22140/$$801716012*. Packaged in heat-sealed plastic bag. || Product Usage: || 4.5mm x 14mm Anterior Cervical Plate System Variable Rescue Screw. The Opteryx¿ Cervical Plate System is intended as a temporary fixation device used for correction and stabilization of the cervical spine. Variable angle screws are included to allow the physician greater flexibility when placing the plates and securing it to the vertebrae.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Innovasis, Inc, 614 E 3900 S, Salt Lake City UT 84107-1902
  • Société-mère du fabricant (2017)
  • Source
    USFDA