The following data is part of a premarket notification filed by Ossdsign Ab with the FDA for Ossdsign Cranial Psi.
| Device ID | K212414 |
| 510k Number | K212414 |
| Device Name: | OSSDSIGN Cranial PSI |
| Classification | Filler, Bone Void, Non-alterable Compound For Cranioplasty |
| Applicant | OssDsign AB Rapsgatan 23A Uppsala, SE Se 754 50 |
| Contact | Ulrik Birgersson |
| Correspondent | David Weissburg David Weissburg 411 Walnut Street #16642 Green Cove Springs, FL 32043 -3443 |
| Product Code | PJN |
| CFR Regulation Number | 882.5330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-03 |
| Decision Date | 2021-10-01 |