21 C.F.R. § 882.5330

Current through October 31, 2024
Section 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).

21 C.F.R. §882.5330