510(k) K171567 ยท OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
IRIX-A Lumbar Integrated Fusion System
| Applicant | X-Spine Systems, Inc., Miamisburg OH, US |
| Decision | Substantially Equivalent, Aug 28, 2017 |
| Received | May 30, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K171567
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 19, 2025 | XTANT Medical Holdings, Inc Irix-A Integrated Lumbar Fusion System, Model Number X080-423011-08PC (Spacer Assy, 42 X 30 X 8, 11mm, PC (STERILE)) and Model Number X080-382819-08PC (Spacer ASSY, 38 X 28 X 8, 19mm, PC, (STERILE)) Open, Classified |
OVD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.