21 CFR 882.5330 — Plate, Cranioplasty, Preformed, Non-Alterable
Neurology (NE) · Part 882 Subpart F—Neurological Therapeutic Devices · § 882.5330
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).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| GXN | Plate, Cranioplasty, Preformed, Non-Alterable | 2 | 55 | Implant |
| PBJ | Cranial Distraction System | 2 | 6 | Implant, Life-Sustaining |
| PJN | Filler, Bone Void, Non-Alterable Compound For Cranioplasty | 2 | 2 | Implant |
