PJN

2 FDA 510(k) clearances · Product code

FDA profile

Official device name: Filler, Bone Void, Non-Alterable Compound For Cranioplasty
Device class: Class II (moderate risk)
Regulation: 21 CFR 882.5330
Medical specialty: Neurology
Flags: Implant
FDA definition: 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 cranial skeleton, and are not intrinsic to the stability of the bony structure. The materials used (e.g., metals, polyether ether ketone (PEEK), etc.) in the construction of the nonalterable cranial bone void fillers are not resorbable and cannot be altered or reshaped at the time of surgery or after implantation without changing the chemical behavior of the material.

Record	Firm	Date
OSSDSIGN Cranial PSI (K212414)	Ossdsign AB	2021-10-01
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)	Ossdsign AB	2019-10-10

Every clearance here is in the API, with alerts when new ones post.