PJN · Filler, Bone Void, Non-Alterable Compound For Cranioplasty
Neurology · 21 CFR 882.5330 · Class 2
Overview
| Product Code | PJN |
|---|---|
| Device Name | Filler, Bone Void, Non-Alterable Compound For Cranioplasty |
| Regulation | 21 CFR 882.5330 |
| Device Class | Class 2 |
| Review Panel | Neurology |
| Implant | Yes |
Identification
A preformed nonalterable cranioplasty plate is a device that is implanted in a patient to repair a skull defect and is constructed of a material, e.g., stainless steel or vitallium, that cannot be altered or reshaped at the time of surgery without changing the chemical behavior of the material.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K212414 | OSSDSIGN Cranial PSI | Ossdsign AB | Oct 1, 2021 | SESE |
| K190523 | Cranial PSI Accessory Anatomical Model Original, Cranial PSI Accessory Anatomical Model Modified, Cranial PSI Accessory Plastic Drawing Guide, Cranial PSI Accessory Cranial Implant Trial | Ossdsign AB | Oct 10, 2019 | SESE |
Top Applicants
- Ossdsign AB — 2 clearances
