Device product
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.
Z-0966-2017
Product summary
- Firm
- Amendia, Inc
- Event
- Event 75857
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6 devices
- Official record key
device-enforcement:Z-0966-2017
Official wording
Reason: Absent tantalum market pin.
Code information: Part Number 08-170-1010 - Lot Number 134926; Part Number 08-170-1011 - Lot Number 134927; Part Number 08-170-1006 - Lot Number 134929; Part Number 08-170-1008 - Lot Number 134931
Distribution pattern: US Distribution to GA only.
Derived failure modes
-
Unknown
Absent tantalum market pin.