Cranial PSI Accessory – Anatomical Model Original, Cranial PSI Accessory – Anatomical Model Modified, Cranial PSI Accessory – Plastic Drawing Guide, Cranial PSI Accessory – Cranial Implant Trial

K190523 is the FDA 510(k) clearance record for Cranial PSI Accessory – Anatomical Model Original, Cranial PSI Accessory – Anatomical Model Modified, Cranial PSI Accessory – Plastic Drawing Guide, Cranial PSI Accessory – Cranial Implant Trial, a class II device, cleared for Ossdsign AB on 2019-10-10 under FDA product code PJN (Filler, Bone Void, Non-Alterable Compound For Cranioplasty). FDA's definition for product code PJN reads: "A nonalterable cranial bone void filler is a device that is created from patient-specific computerized tomography (CT) imaging data and intended to fill bony voids, defects, and contour irregularities in non-load bearing regions of the...". FDA records list 6 510(k) clearances for Ossdsign AB, from 2014-10-03 to 2023-09-15. As of 2026-09-10, FDA records show no recalls naming K190523.