510(k) K170830 ยท OVE Intervertebral Fusion Device With Integrated Fixation, Cervical
Unison-C Anterior Cervical Fixation System
| Applicant | Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc., Marquette MI, US |
| Decision | Substantially Equivalent, Jun 28, 2017 |
| Received | Mar 20, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K170830
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.