Foundation NonPorous Hip System

  • Model / Serial
    All devices packaged prior to July 1, 2008. Model/Catalog Number: 460-01-090, 460-01-105, 460-01-120, 460-01-135, 460-01-150, 460-01-165
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution -- USA ( nationwide ) including the states of WI, NY, MO, TX, FL, CA, UT, AZ, Puerto Rico, and the country Japan.
  • Product Description
    FOUNDATION HIP SYSTEM Series 460 Hip Stem STERILE R CEMENTED Sz 16.5mm || DJO Surgical 9800 Metric Blvd., Austin, TX 78758 || The Foundation Non-Porous Stem is intended for treatment of patients who are candidates for total or hemi-hip arthroplasty because the natural femoral head and neck have been affected by osteoarthritis, inflammatory arthritis, traumatic arthritis, rheumatoid arthritis, avascular necrosis, or femoral neck fracture, and revision arthroplasty where bone loss is minimal. These devices are intended to aid the surgeon in relieving the patient of hip pain and restoring hip motion and are intended to be used with bone cement.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Encore Medical, Lp, 9800 Metric Blvd, Austin TX 78758
  • Source
    USFDA