FDA-Device2017-01-18Class II

Ceres-C Standalone Cervical Interbody The product is a stand-alone anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at the one level from C2-T1.

Amendia, Inc
Hazard

Absent tantalum market pin.

Sold states
US Distribution to GA only.
Affected count
6 devices
Manufactured in
1755 W Oak Pkwy, Marietta, GA, United States
Products
Ceres-C Standalone Cervical Interbody The product is a stand-alone anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at the one level from C2-T1.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0966-2017

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