FDA-Device2015-11-11Class II
MaxAn 4.0mm and 4.5mm fixed screws, used in the MaxAn Anterior Cervical Plate System. The MaxAn Anterior Cervical Plate System is a decompression-based technique for cervical spine stabilization.
Biomet Spine, LLC
Hazard
The packaging of 4.5 mm diameter MaxAn screws identifies/labels the screws as 4.0 mm diameter screws.
Sold states
US Distribution to the states of : NY, MO, and FL
Affected count
17 units
Manufactured in
310 Interlocken Pkwy Ste 120, N/A, Broomfield, CO, United States
Products
MaxAn 4.0mm and 4.5mm fixed screws, used in the MaxAn Anterior Cervical Plate System. The MaxAn Anterior Cervical Plate System is a decompression-based technique for cervical spine stabilization.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0203-2016Don't want to check this manually?
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