PJM · Filler, Bone Void, Alterable Compound For Cranioplasty
Neurology · 21 CFR 882.5320 · Class 2
Overview
| Product Code | PJM |
|---|---|
| Device Name | Filler, Bone Void, Alterable Compound For Cranioplasty |
| Regulation | 21 CFR 882.5320 |
| Device Class | Class 2 |
| Review Panel | Neurology |
| Implant | Yes |
Identification
A preformed alterable cranioplasty plate is a device that is implanted into a patient to repair a skull defect. It is constructed of a material, e.g., tantalum, that can 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 (0 of 0)
No cleared devices on record.
