FDA-Device2019-09-04Class II
Skull Anchor Bolts
Ad-Tech Medical Instrument Corporation
Hazard
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.
Sold states
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.
Affected count
22,810 devices with possible affected supplemetal information
Manufactured in
400 W Oakview Pkwy, N/A, Oak Creek, WI, United States
Products
Skull Anchor Bolts
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2408-2019Don't want to check this manually?
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