510(k) K190523 · PJN Filler, Bone Void, Non-Alterable Compound For Cranioplasty
Cranial PSI Accessory Anatomical Model Original, Cranial PSI Accessory Anatomical Model Modified, Cranial PSI Accessory Plastic Drawing Guide, Cranial PSI Accessory Cranial Implant Trial
| Applicant | Ossdsign AB, Uppsala, SE |
| Decision | Substantially Equivalent, Oct 10, 2019 |
| Received | Mar 4, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190523
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.