510(k) K152972 ยท OVE Intervertebral Fusion Device With Integrated Fixation, Cervical
Amendia Stand-Alone Cervical System
| Applicant | Amendia, Inc., Marietta GA, US |
| Decision | Substantially Equivalent, Jan 14, 2016 |
| Received | Oct 8, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K152972
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 7, 2017 | Amendia, Inc Ceres Self-Drilling Variable Screw 4.0 x 12mm
The Ceres screws are self-drilling variable screws that are intended to be used with the Ceres-C Stand-Alone Cervical System. Terminated |
OVE | None listed |
| Jan 9, 2017 | Amendia, Inc 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 Terminated |
OVE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.