21 CFR 882.5320 — Plate, Cranioplasty, Preformed, Alterable
Neurology (NE) · Part 882 Subpart F—Neurological Therapeutic Devices · § 882.5320
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).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| GWO | Plate, Cranioplasty, Preformed, Alterable | 2 | 42 | Implant |
| PJM | Filler, Bone Void, Alterable Compound For Cranioplasty | 2 | 0 | Implant |
