21 CFR 882.5360 — Fastener, Plate, Cranioplasty
Neurology (NE) · Part 882 Subpart F—Neurological Therapeutic Devices · § 882.5360
Identification
A cranioplasty plate fastener is a screw, wire, or other article made of tantalum, vitallium, or stainless steel used to secure a plate to the patient's skull to repair a skull defect.
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| HBW | Fastener, Plate, Cranioplasty | 2 | 7 | Implant |
