21 CFR § 882.5300 Neurological Devices

§ 882.5300 Methyl methacrylate for cranioplasty.

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

⚠ 2 pending changes to Part 882

(a) Identification. Methyl methacrylate for cranioplasty (skull repair) is a self-curing acrylic that a surgeon uses to repair a skull defect in a patient. At the time of surgery, the surgeon initiates polymerization of the material and forms it into a plate or other appropriate shape to repair the defect.

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

← § 882.5275 Nerve cuff.§ 882.5320 Preformed alterable cranioplasty plate. →