Device Recall PERPOS PLS, CATALOG 's 904501 & 904502

  • Modèle / numéro de série
    CATALOG NO. 9045-01, LOT #'s: 050709-8, 050809-C, 051209-D, 060209-A, 060809-C, 061709-C, 062009-0,  CATALOG NO. 9045-02, LOT #'s: 050809-B, 051309-8,060809-8, 061 709-0,060209-A
  • Classification du dispositif
  • Classe de dispositif
    Unclassified
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide Distribution including CO, CT, FL, KY, LA, MA, MO, NC, NY, OK, OR, TN, TX, VA & WI
  • Description du dispositif
    PERPOS PLS, CATALOG #'s 9045-01 & 9045-02 || A sterile, medical device kit consisting of the components listed in Table 1-1 below. The kit is used by medical professionals to stabilize the spine as an aid to fusion through immobilization of the facet joints.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Interventional Spine Inc, 13700 Alton Pkwy Ste 160, Irvine CA 92618-1618
  • Société-mère du fabricant (2017)
  • Source
    USFDA