Device Recall Reusable BONELOK PLS System;

  • Model / Serial
    CATALOG #'s: 9039-01LOT NUMBERS: 092707-01, 102907, 102907-02 thru -03, 120107-01 thru -10, 050208-21 thru -30, 050208-15 thru -16, 050108-01, 041708-01, 050208-11 thru -20, 060208-01 thru -10, 050208-41 thru -47  CATALOG #'s: 9039-02 LOT NUMBERS: 050208-11 thru -20, 050108-11
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Word wide Distribution: (USA) Nationwide including the states of CO, CT, FL, KY, LA, MA, NC, NY, OK, OR, TN, TX, VA, and WI; and the countries of Italy, Spain, Turkey, and the U.K.
  • Product Description
    Reusable BONE-LOK PLS System; Catalog #'s: 9039-01 and 9039-02. || Interventional Spine, Inc. || A sterile kit used to stabilize the spine as an aid to fusion through immobilization of the facet joints. Sold in Europe.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Interventional Spine Inc, 13700 Alton Pkwy Ste 160, Irvine CA 92618-1618
  • Manufacturer Parent Company (2017)
  • Source
    USFDA