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).