510(k) K150395 ยท MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Omega LIF System
| Applicant | Amendia, Inc., Marietta GA, US |
| Decision | Substantially Equivalent, Aug 10, 2015 |
| Received | Feb 18, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K150395
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 16, 2018 | Spinal Elements AMENDIA Omega Lumbar Interbody Fusion Device, Part Number 72-00-2-092812-11
The OmegaLIF(TM) (LIF(TM)) Expandable Lumbar Interbody Device is designed for use in intervertebral body spinal fusion proc Open, Classified |
MAX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.