510(k) K180728 ยท OWI Bone Fixation Cerclage, Sublaminar
Spinal Elements Cerclage System
| Applicant | Spinal Elements, Inc., Carlsbad CA, US |
| Decision | Substantially Equivalent, Sep 6, 2018 |
| Received | Mar 20, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180728
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.