Blackstone Medical Inc. Firebird Spinal Fixation System

  • 모델명 / 제조번호(시리얼번호)
    Catalog #'s: 77-7630 and 77-8630.  510(k) Information: K081684 (Blackstone Medical Inc.). Lot #: R01. UPC's: M3327776301G and M3327786301H.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution including AZ, NY, TX, MS, LA, FL, NC, and AR.
  • 제품 설명
    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

제조사

  • 제조사 주소
    Orthofix Inc, 3451 Plano Parkway, Lewisville TX 75056-9453
  • 제조사 모회사 (2017)
  • Source
    USFDA