510(k) K161280 ยท OVE Intervertebral Fusion Device With Integrated Fixation, Cervical
Cervical Stand Alone System
| Applicant | Orthofix, Inc., Lewisville TX, US |
| Decision | Substantially Equivalent, Jun 17, 2016 |
| Received | May 6, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K161280
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.