FDA-Device2024-10-23Class II
Cortera Spinal Fixation System Screw, Poly, Solid, 6.5mm x 45mm, REF: 150100-65045
XTANT Medical Holdings, Inc
Hazard
Spinal fixation system implant screws marked "DNI" are not intended to be implanted and may not have been manufactured in accordance with released manufacturing specifications, and if implanted the screws may not have adequate strength or performance.
Sold states
US Nationwide distribution in the states of IL, WI, FL, PA, CA, TX, MI, MO, VA, OH, MA.
Affected count
330
Manufactured in
664 Cruiser Ln, Belgrade, MT, United States
Products
Cortera Spinal Fixation System Screw, Poly, Solid, 6.5mm x 45mm, REF: 150100-65045
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0125-2025Don't want to check this manually?
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