Skull Anchor Bolts
Supplemental information provided with devices may indicate that the subdural electrodes, depth electrodes, and anchor bolts are approved for use in the MR environment, for which they are not approved for such use.
Nationwide distribution to AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. Worldwide distribution to Albania, Argentina, Australia, Austria, Brazil, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Guatemala, Hong Kong, India, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Malaysia, Mexico, Netherlands, Nicaragua, Pakistan, Panama, Poland, Portugal, Puerto Rico, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Syria, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam.
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2408-2019