Code of Federal Regulations (Last Updated: February 15, 2024) |
Title 21 - Food and Drugs |
Chapter I - Food and Drug Administration, Department of Health and Human Services |
SubChapter H - Medical Devices |
Part 882 - Neurological Devices |
Subpart F - Neurological Therapeutic Devices |
§ 882.5320 - Preformed alterable cranioplasty plate.
Latest version.
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§ 882.5320 Preformed alterable cranioplasty plate.
(a) 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.
(b) Classification. Class II (performance standards).