510(k) K180401 · ODP Intervertebral Fusion Device With Bone Graft, Cervical
TiWAVE-C Porous Titanium Cervical Cage
| Applicant | Kalitec Direct, LLC, Orlando FL, US |
| Decision | Substantially Equivalent, Jun 14, 2018 |
| Received | Feb 14, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180401
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.