FDA-Device2013-08-14Class II
Invue Split Driver, Assembly with Handle, Model SI70006 Rev G. Used in conjunction with the Invue Anterior Cervical Plate System under 501(k) clearance number K121060. The Invue Driver is an instrument consisting of a Radel handle, a shaft and hexalobe-like tip with a 4.0mm split, which allows the driver to collapse to fit into a screw and expand to retain the screw.
SpineFrontier, Inc.
Hazard
Device design.
Sold states
Nationwide Distribution including Texas, Ohio, and Missouri.
Affected count
12 devices
Manufactured in
500 Cummings Ctr Ste 3500, N/A, Beverly, MA, United States
Products
Invue Split Driver, Assembly with Handle, Model SI70006 Rev G. Used in conjunction with the Invue Anterior Cervical Plate System under 501(k) clearance number K121060. The Invue Driver is an instrument consisting of a Radel handle, a shaft and hexalobe-like tip with a 4.0mm split, which allows the driver to collapse to fit into a screw and expand to retain the screw.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1927-2013Don't want to check this manually?
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