The following data is part of a premarket notification filed by Ossdsign Ab with the FDA for Cranial Psi.
| Device ID | K161090 |
| 510k Number | K161090 |
| Device Name: | Cranial PSI |
| Classification | Plate, Cranioplasty, Preformed, Non-alterable |
| Applicant | OSSDSIGN AB VIRDINGS ALLE 2 Uppsala, SE Se 754 50 |
| Contact | Ulrik Birgersson |
| Correspondent | David Weissburg WEISSBURG ASSOCIATES 808 WILLIAMSON STREET, SUITE 402 Madison, WI 53703 |
| Product Code | GXN |
| CFR Regulation Number | 882.5330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-18 |
| Decision Date | 2017-01-19 |
| Summary: | summary |