510(k) K212414 ยท PJN Filler, Bone Void, Non-Alterable Compound For Cranioplasty
OSSDSIGN Cranial PSI
| Applicant | Ossdsign AB, Uppsala, SE |
| Decision | Substantially Equivalent, Oct 1, 2021 |
| Received | Aug 3, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212414
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.