Warsaw Orthopedic, Inc. dba Medtronic SOFAMOR DANEK

4 devices in the database

  • Model / Serial
    All lots.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution including states of Arizona, Connecticut, Georgia, Indiana, Minnesota, New Jersey, New York, South Carolina, Texas and Washington.
  • Product Description
    Medtronic TSRH Spinal System, 3Dx Splined Connector, Large; Medtronic Sofamor Danek, Memphis, TN; REF 8351512. || The device is intended for orthosis, spinal pedicle fixation for degenerative disc disease. The product is used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients; posterior non-cervical, non-pedicle screw fixation or for anterior use for certain conditions.
  • Model / Serial
    All lots.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution including states of Arizona, Connecticut, Georgia, Indiana, Minnesota, New Jersey, New York, South Carolina, Texas and Washington.
  • Product Description
    Medtronic TSRH 3DX Implant Set; SPS002058. Sets are unlabeled, but contain individually labeled 3Dx Splined Connectors in sizes small, medium and large. || The device is intended for orthosis, spinal pedicle fixation for degenerative disc disease. The product is used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients; posterior non-cervical, non-pedicle screw fixation or for anterior use for certain conditions.
  • Model / Serial
    Lot Numbers: W07G2386, W07G2387, W07G2388, W07G2389, W07G2751, W07H0440, W07H1809, and W07H1810.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - USA, Australia, Hong Kong and the Netherlands.
  • Product Description
    Medtronic Sofamor Danek COLORADO 2" SPINAL SYSTEM Break-Off Nut, non-sterile, RX; Catalog Number 8634111, Medtronic, Memphis, TN 38138.
  • Model / Serial
    All lots.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide, including USA, Hong Kong, India, Mexico, Netherlands, Qatar, Saudi Arabia and South Korea.
  • Product Description
    Medtronic Sofamor Danek METRx (TM) System Bayonet Electrosurgical Pencil, sterile, Manufactured at Warsaw, Indiana; REF (P/N) 9560575.