510(k) K153352 · OVE Intervertebral Fusion Device With Integrated Fixation, Cervical
Vertu® & Vertu® Ti-Bond and Crystal® & Crystal® Ti-Bond Cervical Interbody System
| Applicant | Spinal Elements, Inc., Carlsbad CA, US |
| Decision | Substantially Equivalent, Aug 1, 2016 |
| Received | Nov 20, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153352
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.