Title 21: Food and Drugs
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/ PART 882 - NEUROLOGICAL DEVICES
/ Subpart F - Neurological Therapeutic Devices / § 882.5330 Preformed nonalterable cranioplasty plate.
§ 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).