21 C.F.R. § 882.5320

Current through October 31, 2024
Section 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).

21 C.F.R. §882.5320