510(k) K181115 ยท ODP Intervertebral Fusion Device With Bone Graft, Cervical
CxHA PEEK Cervical IBF System
| Applicant | Innovasis, Inc., Salt Lake City UT, US |
| Decision | Substantially Equivalent, Jul 16, 2018 |
| Received | Apr 27, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181115
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.