§ 882.5330. Preformed nonalterable cranioplasty plate.
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/us/cfr/t21/s§ 882.5330·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(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).