510(k) K170855 ยท OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
T-Rex Standalone ALIF
| Applicant | Siats, LLC, Tulsa OK, US |
| Decision | Substantially Equivalent, Sep 7, 2017 |
| Received | Mar 22, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K170855
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.