510(k) K133947 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, Jul 29, 2014 |
| Received | Dec 23, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K133947
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.