510(k) K162944 ยท OVE Intervertebral Fusion Device With Integrated Fixation, Cervical
Irix-C Cervical Integrated Fusion System
| Applicant | X-Spine Systems, Inc., Miamisburg OH, US |
| Decision | Substantially Equivalent, Nov 7, 2016 |
| Received | Oct 21, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162944
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.