Blackstone Medical Inc. Firebird Spinal Fixation System

  • Modèle / numéro de série
    Catalog #'s: 77-7630 and 77-8630.  510(k) Information: K081684 (Blackstone Medical Inc.). Lot #: R01. UPC's: M3327776301G and M3327786301H.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide Distribution including AZ, NY, TX, MS, LA, FL, NC, and AR.
  • Description du dispositif
    BLACKSTONE Medical Inc. Firebird Spinal Fixation System 6.5mm x 30mm Bone Screw, Self Tapping, Cannulated. BLACKSTONE Medical Inc. Firebird Spinal Fixation System 6.5mm x 30mm Multi-Axial Screw, Self Tapping, Cannulated. || The Multi-Axial Screw is a pedicle screw which is inserted into the pedicle with the use of the Multi-Axial Screw Driver. The component is used within the Firebird Spinal Fixation System. The screw is cannulated and available modular (77-7630, pre-assembled with screw head) or non-modular (77-8630, without screw head). Product Code: NKB-Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease. Class II. || Intended for use when implanted over a guide wire for additional accuracy with reference to the pedicle.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Orthofix Inc, 3451 Plano Parkway, Lewisville TX 75056-9453
  • Société-mère du fabricant (2017)
  • Source
    USFDA