510(k) K150619 ยท ODP Intervertebral Fusion Device With Bone Graft, Cervical
CONSTRUX Mini PEEK Spacer System, CONSTRUX Mini PEEK Ti Spacer System
| Applicant | Orthofix, Inc., Lewisville TX, US |
| Decision | Substantially Equivalent, Sep 11, 2015 |
| Received | Mar 10, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K150619
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.