Devices

Balanced Knee System

  • Model / Serial
    Part # 252-0300, Lot # W007919.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Units were sent to distributors in AZ, CA, FL, MO, OK and TX. Units were also distributed to firm's parent company in Japan.
  • Product Description
    Guide pin (component of the Tibial Punch Guide) of the Balanced Knee System.
  • Manufacturer
    Ortho Development Corporation
  • 1 Event

Manufacturer

Ortho Development Corporation
  • Manufacturer Address
    Ortho Development Corporation, 12187 Business Park Drive, Draper UT 84020
  • Source
    USFDA

One device with a similar name

Learn more about the data here

Device Recall ORTHO DEVELOPMENT BALANCED KNEE SYSTEM
  • Model / Serial
    Lot Number 0054891.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide -- US (states of FL and TX) and Japan.
  • Product Description
    Tibial Tray, component of Ortho Development Balanced Knee System, Nonporous, Sterile R, Size 3, REF 162-1300, Ortho Development, Draper, Utah 84020. || The Balanced Knee System is indicated in the salvage of previously failed surgical attempts where femoral bone loss does not require the use of augments or stem extensions and where collateral ligaments may be relied upon for medial/lateral stability.
  • Manufacturer
    Ortho Development Corporation