21 C.F.R. § 882.5320 Preformed alterable cranioplasty plate.
Title 21 - Food and Drugs
(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).
Title 21: Food and Drugs
PART 882—NEUROLOGICAL DEVICES
Subpart F—Neurological Therapeutic Devices
§ 882.5320 Preformed alterable cranioplasty plate.
