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e-CFR data is current as of February 23, 2021 |
Title 21 → Chapter I → Subchapter H → Part 882 → Subpart F → §882.5330 |
Title 21: Food and Drugs
PART 882—NEUROLOGICAL DEVICES
Subpart F—Neurological Therapeutic Devices
§882.5330 Preformed nonalterable cranioplasty plate.
(a) 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.
(b) Classification. Class II (performance standards).