510(k) K163265 ยท ODP Intervertebral Fusion Device With Bone Graft, Cervical
Kepler II
| Applicant | Orbbo Surgical, LLC, Los Angeles CA, US |
| Decision | Substantially Equivalent, Apr 7, 2017 |
| Received | Nov 21, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K163265
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.