FDA-Device2022-12-28Class II
X-CORE 2 Ti Core, Static. Part of the NuVasive X-Core Expandable VBR System used with spinal fixation.
NuVasive Inc
Hazard
Potential that insert will be unable to disengage from the vertebral body replacement device/implant
Sold states
Worldwide - U.S. Nationwide distribution including in the states of NC, CA, FL, KY, IL, TX, CO, OH, AK, GA, UT, MA, WA, HI, AL, NY, WI, AR, ID, VA, PA, SC, MD, PA, AZ, RI, IN, ME, NJ, MI, TN, MN, OR, OK, WY, and Puerto Rico. The countries of Australia, Belgium, Brazil, Colombia, Germany, Italy, Spain, and United Kingdom.
Affected count
2,031 devices
Manufactured in
7475 Lusk Blvd, San Diego, CA, United States
Products
X-CORE 2 Ti Core, Static. Part of the NuVasive X-Core Expandable VBR System used with spinal fixation.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0738-2023Don't want to check this manually?
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