Orthofix Inc

3 devices in the database

  • Model / Serial
    Part #68-0111, Lot #16518-LC18.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide distribution: USA including states of: CA, CO, FL, LA , MD, MI, MO, NJ, NY, OH, TN, VA, and WA.
  • Product Description
    ORTHOFIX Firebird Spinal Fixation System, Pedicle Screw Spinal System, Reduction Case, Part #68-0111, Lot #16518-LC18. || Intended for use in conjunction with Multi-Axial Reduction Screw Assemblies. During assembly of a construct, the Anti-Splay Cap locks onto the Screw Body to prevent the Screw Body tabs from splaying (spreading apart). The Anti-Splay Cap is subsequently removed from the Screw Body after assembly of the construct. || The Anti-Splay Cap is a stainless steel machined instrument. The instrument is used within the Firebird Reduction Kit (Domestic, 44-9050) and the ICON Reduction Kit (International, 68-0010). || Product Code: NKB-Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease. Class II.
  • Model / Serial
    Catalog #'s: 77-7630 and 77-8630.  510(k) Information: K081684 (Blackstone Medical Inc.). Lot #: R01. UPC's: M3327776301G and M3327786301H.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution including AZ, NY, TX, MS, LA, FL, NC, and AR.
  • Product Description
    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.
  • Model / Serial
    Lot numbers L0J124, L0D175, L9K206 and L9E218
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA, including the states of AL, AR, CA, CT, FL, LA, MI, MO, NC, NJ, NY, PA, SC, and TX, and the country of Spain.
  • Product Description
    Orthofix Bone Marrow Aspiration Needle, Catalog number 21-5000, 21-5011, Distributed By: Orthofix Inc, 1720 Bray Central Drive, McKinney, TX 75068-8207. Product includes handle, stylet, cannula, probe, probe guide, and universal cap. Cannula is available as an 8 gauge needle or 11 gauge needle.

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