21 CFR § 882.5360 Neurological Devices

§ 882.5360 Cranioplasty plate fastener.

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

⚠ 2 pending changes to Part 882

(a) Identification. A cranioplasty plate fastener is a screw, wire, or other article made of tantalum, vitallium, or stainless steel used to secure a plate to the patient's skull to repair a skull defect.

(b) Classification. Class II (performance standards).

← § 882.5330 Preformed nonalterable cranioplasty plate.§ 882.5500 Lesion temperature monitor. →