510(k) K161090 ยท GXN Plate, Cranioplasty, Preformed, Non-Alterable
Cranial PSI
| Applicant | Ossdsign AB, Uppsala, SE |
| Decision | Substantially Equivalent, Jan 19, 2017 |
| Received | Apr 18, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161090
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.