Filler, Bone Void, Non-Alterable Compound For Cranioplasty
Regulation 882.5330
0510(k)s in 12 months (2 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in PJN
| Company | 510(k)s | Recalls |
|---|---|---|
| Ossdsign AB | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 1, 2021 | K212414 | OSSDSIGN Cranial PSI Ossdsign AB, SE | PJN |
| Oct 10, 2019 | K190523 | Cranial PSI Accessory Anatomical Model Original, Cranial PSI Accessory Anatomical Model Modified, Cranial PSI Access Ossdsign AB, SE | PJN |
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