510(k) K151322 ยท MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Amendia Interbody Fusion Devices
| Applicant | Amendia, Inc., Marietta GA, US |
| Decision | Substantially Equivalent, Sep 10, 2015 |
| Received | May 18, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K151322
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 20, 2016 | Amendia, Inc Zeus-P Lumbar Interbody Device Terminated |
MAX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.