21 CFR § 882.5320 Neurological Devices

§ 882.5320 Preformed alterable cranioplasty plate.

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

⚠ 2 pending changes to Part 882

(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).

← § 882.5300 Methyl methacrylate for cranioplasty.§ 882.5330 Preformed nonalterable cranioplasty plate. →