21 CFR § 882.5330 Neurological Devices

§ 882.5330 Preformed nonalterable cranioplasty plate.

Current through Sep 8, 2026 · Read all of Part 882

⚠ 2 pending changes to Part 882

(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).

← § 882.5320 Preformed alterable cranioplasty plate.§ 882.5360 Cranioplasty plate fastener. →