FDA-Device2013-09-18Class II
StaXx¿ IB Convex Expandable Implant (25 x 12 x 9 mm), Intervertebral Fusion Device, Lumbar; Catalog Number 11 -1902. Indicated for intervertebral body fusion procedures in skeletally mature patients.
Spine Wave, Inc.
Hazard
A component Superior endplate manufactured from a different polymer than specified
Sold states
Distributed in the states of FL and OR.
Affected count
17 units
Manufactured in
3 Enterprise Dr Ste 302, N/A, Shelton, CT, United States
Products
StaXx¿ IB Convex Expandable Implant (25 x 12 x 9 mm), Intervertebral Fusion Device, Lumbar; Catalog Number 11 -1902. Indicated for intervertebral body fusion procedures in skeletally mature patients.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2187-2013Don't want to check this manually?
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