iBalance(R) UKA, Femoral Cemented, Size 3, Left Medial/Right LATERAL

  • Modèle / numéro de série
    batch 10123297
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution - US including SD, NV, NC, CA, MD, AZ, CA, LA, FL, PA, TX, NY, GA, and Internationally to GERMANY, POLAND
  • Description du dispositif
    iBalance(R) UKA, Femoral Cemented, Size 3, Left Medial/Right LATERAL, REF AR 501-UFLC, QTY 1, Rx ONLY, STERILE R, Arthrex, Inc., Naples, FL || Indicated for use in uni-compartmental knee arthroplasty as a result of: 1. Moderately disabling joint disease of the knee resulting from painful osteoarthritis or posttraumatic arthritis. 2. Correction of functional deformity. 3. Revision of previous unsuccessful uni-compartmental knee replacement or other procedure. 4. As an alternative to tibial osteotomy in patients with uni-compartmental osteoarthritis.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Arthrex, Inc., 1370 Creekside Blvd, Naples FL 34108-1945
  • Société-mère du fabricant (2017)
  • Source
    USFDA