510(k) K161993 · OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Leva® Anterior Interbody System
| Applicant | Spine Wave, Inc., Shelton CT, US |
| Decision | Substantially Equivalent, Nov 22, 2016 |
| Received | Jul 19, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161993
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.