510(k) K133218 · OVE Intervertebral Fusion Device With Integrated Fixation, Cervical
Crystal ®; Mosaic ®; Vertu ®
| Applicant | Spinal Elements, Inc., Carlsbad CA, US |
| Decision | Substantially Equivalent, Dec 10, 2014 |
| Received | Oct 18, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K133218
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.